LC determination of rosiglitazone in bulk and pharmaceutical formulation
ABSTRACT An isocratic reversed phase liquid chromatographic (RP-LC) method has been developed and subsequently validated for the determination of rosiglitazone and its related impurities. Separation was achieved with a Symmetry C18 column and sodium phosphate buffer (pH adjusted to 6.2):acetonitrile (50:50, v/v) as eluent, at a flow rate of 1.0 ml/min. UV detection was performed at 245 nm. The method is simple, rapid, selective and stability indicating. Indole was used as internal standard for the purpose of quantification of rosiglitazone. The described method is linear over a range of 0.45-10 microg/ml for related impurities and 180-910 microg/ml for assay of rosiglitazone. The method precision for the determination of assay and related compounds was below 1.0 and 3.6% RSD, respectively. The mean recoveries of impurities were found to be in the range of 95-102%. The percentage recoveries of Active Pharmaceutical Ingredient (API) from dosage forms ranged from 99.02 to 101.30. The method is useful in the quality control of bulk manufacturing and also in pharmaceutical formulations.
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ABSTRACT: Abstract Impurities are nothing but the unidentified, unintended substance present along with desired substance. The newer regulations of US FDA, MHRA intends for the requirements of impurities rather than purity of pharmaceuticals. The impurity profiling of pharmaceuticals can be done by using various analytical methods like UV, HPLC, LC-MS, GC-MS, SCFC etc. Mostly RP-HPLC method commonly adopted for the qualification as well as quantification of impurities. The present review is an attempt made in the respect of highlighting the some important methods, quality guidelines and applications of impurity profiling. Keywords: Impurity, quality control, pharmaceuticals, impurity fate mapping, analytical techniques.
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ABSTRACT: Rimonabant is an antiobesity drug which is CB1 cannabinoid receptor antagonist. Its main avenue of effect is reduction in appetite. So far only HPLC methods of analysis exist for the routine examination of drug. An attempt is hereby made to develop a simple spectrophotometric method for determination of drug from tablet dosage form. Rimonabant shows a maximum absorbance at 230 nm. Beer's law was obeyed in the concentration range of 10-25 µg/ml. The method was validated statistically and recovery studies carried out.
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ABSTRACT: A simple and sensitive method for separation and quantitative determination of antidiabetic drugs in pharmaceutical preparations has been established and validated. Commercial formulations of five antidiabetic drugs (metformin, pioglitazone, rosiglitazone, glibenclamide, and gliclazide) were chosen for the studies. The compounds were extracted, isolated, purified, recrystallized, and characterized by measurement of melting point, lambda(max), and IR. Quantitative determination was performed by HPLC, TLC, and column chromatography supplemented with UV spectrophotometry. Two of the combinations, metformin + pioglitazone and metformin + gliclazide, were separated by open-column chromatography. Detection was by UV spectrophotometry in HPLC and by use of iodine vapor in TLC.JPC - Journal of Planar Chromatography - Modern TLC 08/2006; 19(110):288-296. DOI:10.1556/JPC.19.2006.4.6 · 0.67 Impact Factor