Spectrophotometric methods for the simultaneous analysis of meclezine hydrochloride and pyridoxine hydrochloride in bulk drug and pharmaceutical formulations.
ABSTRACT Three new spectrophotometric procedures for the simultaneous determination of pyridoxine hydrochloride and meclezine hydrochloride are described. The first method depends on the application of simultaneous equation to resolve the interference due to spectral overlapping. The analytical signals were measured at 231 and 220 nm. Calibration graphs were established for 1 to 20 microGmL(-1) for pyridoxine hydrochloride and 0.5 to 10 microGmL(-1) for meclezine hydrochloride in binary mixture. In the second method, the determination of pyridoxine hydrochloride and meclezine hydrochloride was performed by measuring the absorbances at 290 and 235 nm in the simple absorbance spectra of their mixture. In third method a yellowish orange complex of pyridoxine hydrochloride was formed with ferric chloride, which absorbs in the visible region with lambda(max) at 445 nm. Calibration curve of complex formation range was conducted in between 20 to 250 microGmL(-1). These methods were validated with respect to accuracy, precision, linearity, limit of detection and quantification. Regression analysis of Beer's plot showed good correlation in a general concentration range of 1 to 20 microGml(-1) with correlation coefficient (r = 0.9999 and 0.9999; CV < 0.858) for pyridoxine hydrochloride, whereas meclezine hydrochloride concentration range 0.5 to 10 microGmL(-1) with correlation coefficient (r = 0.9998 and 0.9998; CV < 0.826). These methods can be readily applied, without any interference from the excipients. The suggested procedures were successfully applied to the determination of these compounds in synthetic mixtures and in pharmaceutical preparations, with high percentage of recovery, good accuracy and precision.
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ABSTRACT: A simple, specific, accurate, precise stability indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of pyridoxine hydrochloride (PYH) and meclizine hydrochloride (MEH). An isocratic separation of PYH and MEH were achieved on C 18, 250 × 4.6 mm ID, 5 μm particle size columns at column oven temperature 37°C with a flow rate of 0.5 mL min−1 and using a diode array detector to monitor the detection at 254 nm. The mobile phase consisted of buffer : acetonitrile : trifluoroacetic acid at a ratio of 30 : 70 : 0.1 (v/v). The retention times of PYH and MEH was found to be 5.25 and 10.14 min, respectively. Suitability, specificity, linearity, accuracy, precision, stability, and sensitivity of this method for the quantitative determination of the drugs were proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) Q2 (R1) guidelines. The proposed method is reliable and robust and can be used as quality control tool for the estimation of these drugs in combined pharmaceutical solid dosage forms.05/2013; 2013. DOI:10.1155/2013/747060
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ABSTRACT: Meclizine is an antihistamine and has been widely used for prophylactic treatment of motion sickness. To facilitate its pharmacokinetic study in human subjects, a high performance liquid chromatography-mass spectrometric method employing positive electrospray ionization was developed for the determination of meclizine concentration in human plasma. Meclizine together with the internal standard (flunarizine) was extracted from 0.1 ml of human plasma by protein precipitation using acetonitrile. The chromatography was performed using a Zorbax SB-C18 column (150 × 2.1mm, 5 μm, Agilent) with the mobile phase consisting of acetonitrile and 0.2% formic acid containing 2mM amino acetate. Multiple reaction monitoring was used for quantification. The validation of the method including sensitivity, linearity, reproducibility and stability was examined. The lower limit of quantification (LLOQ) of the developed assay method for meclizine was 0.5 ng/ml and the linear calibration curve was acquired with R² > 0.99 between 0.5 and 200ng/ml. The intra-day and inter-day variation of the current assay was evaluated with the coefficient of variations (CVs%) within 12.92% at LLOQ and 7.15% for other quality control samples, whereas the mean accuracy ranged from 99.2% to 102.7%. The samples were stable under the storage conditions at least for a month. The present method provides a robust, fast and sensitive analytical tool for meclizine in human plasma and has been successfully applied to a clinical pharmacokinetic study in 20 subjects.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences 01/2011; 879(1):95-9. DOI:10.1016/j.jchromb.2010.11.022 · 2.69 Impact Factor