Patricia M Castellano

Rosario National University, Rosario, Santa Fe, Argentina

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Publications (23)56.72 Total impact

  • Silvana E. Vignaduzzo · María A. Operto · Patricia M. Castellano
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    ABSTRACT: A dissolution test method and an analytical procedure by HPLC were developed and validated for the evaluation of the dissolution of tablets containing albendazole and praziquantel. Two different commercially tablets containing 500 mg of albendazole and 50 mg of praziquantel for veterinary use were selected for this study. A dissolution medium containing a mixture of 300 mL ethanol and 600 mL of 0.1 mol L-1 HCl was found suitable to ensure sink conditions. USP Apparatus 2, 900 mL dissolution medium and 75 rpm were fixed. Dissolution profiles were generated at 45 min. Dissolution samples were analyzed with a reversed-phase high-performance liquid chromatography (RP-HPLC) method with ultraviolet (UV) detection at 210 nm, developed and validated for this purpose. Each product was also assayed for analyte content according to USP 35. The dissolution test described here could be proposed as a means of assessing finished product quality.
    No preview · Article · Apr 2015 · Journal of the Brazilian Chemical Society
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    Romina M. Bianchini · Patricia M. Castellano · Teodoro S. Kaufman
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    ABSTRACT: Export Date: 24 April 2013, Source: Scopus, CODEN: JLCTF, :doi 10.1080/10826076.2011.615094, Language of Original Document: English, Correspondence Address: Kaufman, T.S.; Department of Organic Chemistry, National University of Rosario, Institute of Chemistry of Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario (S2002LRK), Argentina; email: kaufman@iquir-conicet.gov.ar, : Chemicals/CASvalsartan, 137862-53-4, Tradenames: Prostar 210, Varian, United States, Manufacturers: Varian, United States, References: Thurmann, P.A., Valsartan: A Novel Angiotensin Type 1 Receptor Antagonist (2000) Expert Opin. Pharmacother., 1, pp. 337-350;
    Full-text · Article · May 2012 · Journal of Liquid Chromatography & Related Technologies
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    Silvana E. Vignaduzzo · Patricia M. Castellano · Teodoro S. Kaufman
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    ABSTRACT: The novel triple combination between Amlodipine (AML), Hydrochlorothiazide (HCT), and Valsartan (VAL) provides a new option for treating hypertension. The development and validation of an HPLC method for their simultaneous determination in pharmaceutical combinations, employing experimental design strategies, is reported. The drugs were separated on a C18 column at 30°C, using a 38:62 (v/v) mixture of 30 mM phosphate buffer (pH 5.5) and MeOH as mobile phase, delivered at 1.0 mL min. Detection was performed at 234 nm.Despite the wide difference in analytes’ concentrations, the method showed good linearity (r > 0.995) in the ranges 7.0–13.0 µg mL, 17.6–32.8 µg mL, and 226.2–420.2 µg mL for AML, HCT, and VAL, respectively, being specific (peak purity >0.999), accurate (bias of analyte recoveries
    Full-text · Article · Nov 2011 · Journal of Liquid Chromatography & Related Technologies
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    ABSTRACT: A capillary zone electrophoresis method for the simultaneous determination of pridinol mesylate (PRI) and meloxicam (MEL) employing epinastine hydrochloride and piroxicam as internal standards, was developed and optimized employing experimental design and response surface methodologies. The separation was optimally achieved in less than 2min at 30kV in an uncoated fused-silica capillary (41.4cm×75μm I.D.), employing an 18mmolL−1 sodium phosphate buffer solution (pH 5.90) at 25°C. Samples were injected in hydrodynamic mode (50mbar, 5s) and the analytes were spectrophotometrically detected at 200nm. Method robustness was demonstrated by ANOVA of determinations performed under conditions slightly different from the optimum. The method was validated regarding separation selectivity (peak purity factors>0.99), linearity and range (PRI=17.6–31.4mgL−1; MEL=66.5–122.5mgL−1), accuracy (PRI=100.2–101.9%; MEL=98.9–100.7%) and precision. The RSD values obtained were ≤1.3% for injection repeatability and ≤1.9% for intra-day precision. The limits of detection (1.0 and 0.9mgL−1) and quantification (3.3 and 16.5mgL−1) of PRI and MEL, respectively, were also determined. The method was successfully applied to the determination of both drugs in three brands of tablet formulations. No statistically significant differences were observed when these results were compared with those of a RP-HPLC method. KeywordsCapillary zone electrophoresis–Experimental designs–Meloxicam–Pridinol
    Full-text · Article · Oct 2011 · Chromatographia
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    Romina M Bianchini · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: A photostability study of Valsartan (VAL) is reported. Exposure of the drug to UV-vis radiation (λ > 320 nm) yielded two previously unknown compounds, which were detected by HPLC. Preparative amounts of the new potential degradation products (DP-1 and DP-2) were obtained by submitting VAL bulk drug to extensive photodegradation. The impurities were isolated by preparative normal phase column chromatography. Analytical information from the infrared, nuclear magnetic resonance and mass spectral data of the degradation products revealed their structures as N-[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-N-isobutylpentanamide (DP-1) and N-(diazirino[1,3-f]phenanthridin-4-ylmethyl)-N-isobutylpentanamide (DP-2). DP-1 arose from decarboxylation of VAL, while DP-2 results from further loss of nitrogen from the tetrazole motif of DP-1, with concomitant cyclization to yield a tetracyclic diazacyclopropene derivative.
    Full-text · Article · Aug 2011 · Journal of pharmaceutical and biomedical analysis
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    Silvana E. Vignaduzzo · Patricia M. Castellano · Teodoro S. Kaufman
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    ABSTRACT: The development and validation of an HPLC method for the determination of pridinol and diclofenac in their combined formulations and the simultaneous limit testing of diclofenac related compound A is described. The separation was performed on a C18 column. Experimental design and response surface strategies were employed for optimizing detection wavelength (225 nm) and mobile phase composition [MeOH:2-propanol:phosphate buffer (50 mM, pH 5.5), 48:9:43 (v/v/v), 1 mL min−1], and for validation purposes. The method was successfully applied to the quality control of commercial brands of tablets and capsules. Found impurity levels were below 0.1% (LOQ = 0.02%). Stressed samples were also evaluated.
    Full-text · Article · Nov 2010 · Journal of Liquid Chromatography & Related Technologies
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    S E Vignaduzzo · P M Castellano · T S Kaufman
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    ABSTRACT: The association of meloxicam and pridinol is indicated for treating muscular contractures and low back pain. A dissolution test for the meloxicam-pridinol combined tablet formulation was developed and validated, using a suitable HPLC method for simultaneously quantitating both dissolved drugs. The optimized conditions include the use of USP apparatus 2 at a paddle rotation rate of 75 rpm and 900 ml of 50 mM phosphate buffer (pH= 7.5) as dissolution medium, at 37.0±0.5°. The test, which demonstrated to be robust against small changes in bath temperature, paddle rotation speed and pH of the dissolution medium, was applied to two different brands of tablets; the corresponding dissolution profiles were constructed and both brands showed to dissolve at least 75% of the drugs at the 45 min time point.
    Full-text · Article · Mar 2010 · Indian Journal of Pharmaceutical Sciences
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    Romina M Bianchini · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: A simple high performance liquid chromatographic method for the determination of process-related impurities in bulk drug of the central anticholinergic compound pridinol mesylate, has been developed and validated. Spectroscopically characterized synthetic impurities were used as standards. The chromatographic separation was optimized employing an experimental design strategy, and was achieved on a C(18) column with a mobile phase containing 50mM potassium phosphate buffer (pH 6.4), MeOH and 2-propanol (20:69:11, v/v/v), delivered at a flow rate of 1.0mLmin(-1). UV detection was performed at 245nm. The optimized method was thoroughly validated, demonstrating to be selective, when the chromatogram was recorded with a diode-array detector and peak purities were evaluated (>0.9995). The method is robust and linear (r(2)>0.99) over the range 0.05-2.5% (5-250% with regards to the 1% specification limit for both process-related impurities); it is also precise, regarding repeatability (RSD</=1.5% for all of the analytes) and intermediate precision aspects and LOQ values for the impurities are below 0.01%. Method accuracy, evidenced by low bias of the results and analyte recoveries in the range of 99.1-102.7%, was assessed at five analyte concentration levels. The usefulness of the determination was also demonstrated through the analysis of different lots of pridinol mesylate bulk substance. The results indicate that the method is suitable for the quality control of the bulk manufacturing of pridinol mesylate drug substance.
    Full-text · Article · Nov 2009 · Analytica chimica acta
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    Rubén M Maggio · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: A simple chemometric approach to differentiate among the three crystalline polymorphs of the model drug Furosemide (FUR) in a pharmaceutical dosage form is presented. The proposed method is based on the principal component analysis with confidence regions (PCA-CR) comparison of the dissolution profiles of the test pharmaceutical formulation, and formulations containing the different polymorphs, employed as the corresponding references. For the elaboration of the references, FUR polymorphs I, II and III were prepared, characterized and compounded with the excipients found in the test commercial formulation. The dissolutions were carried out in a discriminating HCl-KCl dissolution medium (pH 2.2), and the corresponding profiles were constructed from the absorbances (274 nm) of the dissolution samples. PCA-CR was able to differentiate among the three crystalline polymorphs of FUR and to confirm the presence of polymorph I in the test sample, with 99% statistical confidence. The PCA-CR results were compared with those obtained by a bootstrap-mediated implementation of Moore and Flanner's difference factor (f(2)). The same conclusion was reached employing an f(2)-based comparison, despite its inability to differentiate between polymorphs II and III. Therefore, PCA-CR may be considered a complementary and useful tool for probing the polymorphic form present in a pharmaceutical formulation.
    Full-text · Article · Jun 2009 · International Journal of Pharmaceutics
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    Romina M Bianchini · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: The stability of pridinol mesylate (PRI) was investigated under different stress conditions, including hydrolytic, oxidative, photolytic and thermal, as recommended by the ICH guidelines. Relevant degradation was found to take place under acidic (0.1N HCl) and photolytic (visible and long-wavelength UV-light) conditions, both yielding the product resulting from water elimination (ELI), while submission to an oxidizing environment gave the N-oxidation derivative (NOX). The standards of these degradation products were synthesized and characterized by IR, (1)H and (13)C NMR spectroscopy. A simple, sensitive and specific HPLC method was developed for the quantification of PRI, ELI and NOX in bulk drug, and the conditions were optimized by means of a statistical design strategy. The separation employs a C(18) column and a 51:9:40 (v/v/v) mixture of MeOH, 2-propanol and potassium phosphate solution (50mM, pH 6.0), as mobile phase, delivered at 1.0 ml min(-1); the analytes were detected and quantified at 220 nm. The method was validated, demonstrating to be accurate and precise (repeatability and intermediate precision levels) within the corresponding linear ranges of PRI (0.1-1.5 mg ml(-1); r=0.9983, n=18) and both impurities (0.1-1.3% relative to PRI, r=0.9996 and 0.9995 for ELI and NOX, respectively, n=18). Robustness against small modifications of pH and percentage of the aqueous mobile phase was ascertained and the limits of quantification of the analytes were also determined (0.4 and 0.5 microg ml(-1); 0.04% and 0.05% relative to PRI for ELI and NOX, respectively). Peak purity indices (>0.9997), obtained with the aid of diode-array detection, and satisfactory resolution (R(s)>2.0) between PRI and its impurities established the specificity of the determination, all these results proving the stability-indicating capability of the method. The kinetics of the degradation of PRI in acid medium was also studied, determining that this is a first-order process with regards to drug concentration, with an activation energy of 25.5 Kcal mol(-1) and a t(1/2)=10,830 h, in 0.1N HCl at 38 degrees C.
    Full-text · Article · Sep 2008 · Journal of Pharmaceutical and Biomedical Analysis
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    Rubén M Maggio · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: A convenient new method for the simultaneous determination of losartan potassium and hydrochlorothiazide, with minimum sample pretreatment, is described. The procedure, based on the multivariate analysis of spectral data in the 220−274 nm region by the partial least squares algorithm, is linear in the concentration range 1.06−5.70 mg L−1 for hydrochlorothiazide and 4.0−22.2 mg L−1 for losartan. It is simple, rapid and robust, allowing accurate and precise results, with drug recovery rates of 99.3 and 100.4% and relative standard deviations of 1.7 and 1.0% obtained for hydrochlorothiazide and losartan, respectively. The method was applied to the simultaneous determination of both analytes in tablets, and it provided good results which were in statistical agreement with those provided by independent HPLC analyses of the samples. The method has also been successfully applied for the construction of drug dissolution profiles of a commercial pharmaceutical preparation containing both analytes. Figure A UV-PLS method for the simultaneous determination of losartan potassium and hydrochlorothiazide in pharmaceutical tablet formulations has been developed and validated
    Full-text · Article · Jul 2008 · Analytical and Bioanalytical Chemistry
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    M.A. Operto · P.M. Castellano · T.S. Kaufman
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    ABSTRACT: With the aim of performing a comparative evaluation of quality characteristics of acetamoniphen tablets (500 mg), mechanic, bioavailability and posology-related quality parameters were studied on 10 different commercial brands, employing tests prescribed by the USP 30, the BP 2007 and the FA VII Ed. These included friability, disintegration, dissolution and uniformity of dose units, besides the assay of the active principle. Nine of the brands complied with all of the tests, while one brand failed in the friability test. Despite that all brands complied with the dissolution test, notorious variations in their dissolution profiles were observed, probably as a result of differences in the quali-quantitative composition of the excipients in the formulae and the pharmaceutical technology employed.
    Full-text · Article · Jul 2008 · LATIN AMERICAN JOURNAL OF PHARMACY
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    Rubén M Maggio · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: A new approach for testing batch "similarity" through comparison of drug dissolution profiles, based on principal component analysis with the establishment of a confidence region (PCA-CR), is presented. The dissolution curves corresponding to three brands each of Furosemide and Acetaminophen tablets, taken as model drugs, were prepared by dissolution measurements at multiple pre-specified time points. Reference and test data were simultaneously subjected to PCA and pairwise comparisons between the dissolution characteristics of lots of the same and different brands were carried out. The comparisons involved plotting the weighed scores of the first two principal components of reference and test lots, while decision about "similarity" was made by checking for inclusion of more than 80% of the tablets of the test lot in the 95% confidence ellipse of the reference samples. Two published datasets were also analyzed in the same fashion and all the results were compared with information provided by the difference (f1) and similarity (f2) factor tests. Unlike the f2 criterion, the proposed method reflects variability within the individual dissolution curves, being also highly sensitive to profile (shape and size) variations. Comparison between the area enclosed by the confidence ellipses of the weighed scores plot and the region obtained from the bootstrap-calculated acceptable values of the corresponding f2 tests suggested that PCA-CR represents, in general, a more discriminating standard.
    Full-text · Article · Jun 2008 · European Journal of Pharmaceutical Sciences
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    Silvana E Vignaduzzo · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: A simple and reliable reversed-phase high-perfomance liquid chromatographic method has been developed and validated for the simultaneous determination of meloxicam and pridinol mesylate in their synthetic mixtures and combined tablet formulations. Both drugs were separated on a 250 mm x 4.6mm C18 column packed with 5 microm particles. The mobile phase, optimized through an experimental design, was a 51:9:40 (v/v/v) mixture of methanol, isopropanol and 50mM potassium phosphate buffer (pH 5.9), pumped at a flow rate of 1.0 ml min(-1). UV detection was performed at 225 nm. The method was validated in the sample concentration ranges of 33.7-61.8 mg l(-1) for meloxicam and 8.8-16.8 mg l(-1) for pridinol mesylate, where it demonstrated good linearity with r=0.9989 and 0.9987 (n=15), respectively. The assay was shown to be repeatable at concentration levels of 70%, 100% and 130%, with relative standard deviation values of 1.09% and 0.82% for meloxicam and pridinol, respectively. For independent 100% level samples, the intra-day precision was 0.4% and 1.0% while the intermediate precision was 0.7% and 1.0% for the drugs. The method demonstrated to be robust, resisting to small deliberate changes in pH, flow rate and composition (organic:aqueous ratio) of the mobile phase. The LOD values were 0.22 and 0.20 mg l(-1), while the LOQ were 1.7 and 1.1 mg l(-1), for meloxicam and pridinol, respectively. The applicability of the method was demonstrated by determining the drug content of two commercial pharmaceutical formulations, where it exhibited good performance.
    Full-text · Article · Feb 2008 · Journal of Pharmaceutical and Biomedical Analysis
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    Rubén M Maggio · Patricia M Castellano · Silvana E Vignaduzzo · Teodoro S Kaufman
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    ABSTRACT: An alternative method for the determination of fexofenadine (FEX) and pseudoephedrine (PSE) in their combined tablet formulation has been developed, employing the partial least squares (PLS) analysis of spectral data of the analytes in their pharmaceutical association. A full-factorially designed set of 16 synthetic samples was employed for calibration purposes. The calibration models were constructed with wavelengths selection, in the ultraviolet region, according to their predictive ability. These were validated internally by the leave-one-out procedure and externally, employing appropriate sets of validation samples. The described method was linear for both analytes, over the range 160.6-301.2 mg L(-1) for FEX (R(2)=0.9993) and between 325.6 and 610.5 mg L(-1) for PSE (R(2)=0.9992). It was accurate, exhibiting 99.8% and 99.9% drug recoveries for FEX and PSE, respectively (N=9), while in the intermediate precision experiment relative standard deviations were 1.4% for FEX and 1.2% for PSE. The contents of both analytes were assayed in commercial tablets employing this method and the results were compared with those furnished by HPLC, being in good statistical agreement. The method represents an improvement over the first derivative of spectral ratio (DSR) technique and allows high sample throughput with minimum reagent consumption and waste generation. The obtained results confirm that the method is highly suitable for its intended purpose.
    Full-text · Article · Jan 2008 · Journal of Pharmaceutical and Biomedical Analysis
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    Romina M. Bianchini · Patricia M. Castellano · Teodoro S. Kaufman
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    ABSTRACT: A simple and reliable reversed-phase high-perfomance liquid chromatographic method has been developed and validated for the simultaneous determination of meloxicam and pridinol mesylate in their synthetic mixtures and combined tablet formulations. Both drugs were separated on a 250mm×4.6mm C18 column packed with 5 �m particles. The mobile phase, optimized through an experimental design, was a 51:9:40 (v/v/v) mixture of methanol, isopropanol and 50mM potassium phosphate buffer (pH 5.9), pumped at a flow rate of 1.0 ml min−1. UV detection was performed at 225 nm. The method was validated in the sample concentration ranges of 33.7–61.8 mg l−1 for meloxicam and 8.8–16.8 mg l−1 for pridinol mesylate, where it demonstrated good linearity with r = 0.9989 and 0.9987 (n = 15), respectively. The assay was shown to be repeatable at concentration levels of 70%, 100% and 130%, with relative standard deviation values of 1.09% and 0.82% for meloxicam and pridinol, respectively. For independent 100% level samples, the intra-day precision was 0.4% and 1.0% while the intermediate precision was 0.7% and 1.0% for the drugs. The method demonstrated to be robust, resisting to small deliberate changes in pH, flow rate and composition (organic:aqueous ratio) of the mobile phase. The LOD values were 0.22 and 0.20 mg l−1, while the LOQ were 1.7 and 1.1 mg l−1, for meloxicam and pridinol, respectively. The applicability of the method was demonstrated by determining the drug content of two commercial pharmaceutical formulations, where it exhibited good performance.
    Full-text · Article · Jan 2008 · Journal of Pharmaceutical and Biomedical Analysis
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    Silvana E Vignaduzzo · Rubén M Maggio · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: Two new analytical methods have been developed as convenient and useful alternatives for simultaneous determination of hydrochlorothiazide (HCT) and propranolol hydrochloride (PRO) in pharmaceutical formulations. The methods are based on the first derivative of ratio spectra (DRS) and on partial least squares (PLS) analysis of the ultraviolet absorption spectra of the samples in the 250-350-nm region. The methods were calibrated between 8.7 and 16.0 mg L(-1) for HCT and between 14.0 and 51.5 mg L(-1) for PRO. An asymmetric full-factorial design and wavelength selection (277-294 nm for HCT and 297-319 for PRO) were used for the PLS method and signal intensities at 276 and 322 nm were used in the DRS method for HCT and PRO, respectively. Performance characteristics of the analytical methods were evaluated by use of validation samples and both methods showed to be accurate and precise, furnishing near quantitative analyte recoveries (100.4 and 99.3% for HCT and PRO by use of PLS) and relative standard deviations below 2%. For PLS the lower limits of quantification were 0.37 and 0.66 mg L(-1) for HCT and PRO, respectively, whereas for DRS they were 1.15 and 3.05 mg L(-1) for HCT and PRO, respectively. The methods were used for quantification of HCT and PRO in synthetic mixtures and in two commercial tablet preparations containing different proportions of the analytes. The results of the drug content assay and the tablet dissolution test were in statistical agreement (p < 0.05) with those furnished by the official procedures of the USP 29. Preparation of dissolution profiles of the combined tablet formulations was also performed with the aid of the proposed methods. The methods are easy to apply, use relatively simple equipment, require minimum sample pre-treatment, enable high sample throughput, and generate less solvent waste than other procedures.
    Full-text · Article · Dec 2006 · Analytical and Bioanalytical Chemistry
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    ABSTRACT: Six 3H-spiro[benzofuran-2,1'-cyclohexane] derivatives were synthesized from naturally occurring filifolinol, and their classical complement pathway inhibitory activity was determined. IC(50) values of the most potent compounds were comparable to the activity of the natural complement inhibitor K76-COOH and some synthetic tricyclic analogs of it.
    Full-text · Article · Nov 2006 · Bioorganic & Medicinal Chemistry Letters
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    Patricia M Castellano · Silvana E Vignaduzzo · Rubén M Maggio · Teodoro S Kaufman
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    ABSTRACT: A new, repeatable, and rapid method has been developed for resolution of binary mixtures of acetaminophen and diclofenac with minimum sample pretreatment and without separation of the analytes. The method, based on the PLS1 processing of absorbance data in the UV region, was successfully used for quantification of the drug content of three tablet preparations. The results obtained were in good agreement with HPLC recovery data. The method also enabled determination of drug-dissolution profiles of these commercial tablets, by simultaneous determination of both analytes during the dissolution test.
    Full-text · Article · Sep 2005 · Analytical and Bioanalytical Chemistry
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    Mónica C F Ferraro · Patricia M Castellano · Teodoro S Kaufman
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    ABSTRACT: Different chemometric methods such as classical least squares (CLS), principal components regression (PCR) and partial least squares with one dependent variable (PLS-1) applied on UV spectral data (0 D) and on their first derivatives (1 D) were evaluated for the simultaneous quantification of samples containing mixtures of amiloride hydrochloride, atenolol, hydrochlorothiazide and timolol maleate. Their performances were compared by means of ANOVA tests, which evidenced that 0 D-PCR, 0D-PLS-1, 1D-PCR, 1D-PLS-1, were reproducible and gave statistically similar results, while 0 D-CLS and 1D-CLS displayed higher variances than the former and failed to comply with the Levene's variance homogeneity test at different stages of the method comparison and validation process. The four statistically equivalent procedures were successfully applied to the analysis of synthetic samples with two to four analytes and to commercial tablet preparations containing amiloride hydrochloride and hydrochlorothiazide alone or in association with atenolol or timolol maleate.
    Full-text · Article · Mar 2004 · Journal of Pharmaceutical and Biomedical Analysis

Publication Stats

326 Citations
56.72 Total Impact Points

Institutions

  • 2001-2015
    • Rosario National University
      • Facultad de Ciencias Bioquímicas y Farmaceúticas (FBIOYF)
      Rosario, Santa Fe, Argentina
  • 2008
    • Instituto de Química Rosario
      Rosario, Santa Fe, Argentina