Development and Validation of RP-HPLC Method for Simultaneous Estimation of Doxylamine Succinate and Pyridoxine Hydrochloride in Bulk and Pharmaceutical Dosage Forms

摘要

The present paper illustrates about development and validation of a new, simple, precise and accurate RP-HPLC method with enhanced sensitivity for the simultaneous determination of Doxylamine Succinate (DAS) and Pyridoxine Hydrochloride (PDH) in bulk and its dosage forms. The drug showed good absorbance in mobile phase at 263 nm. Under the optimized conditions, linear relationship with good correlation coefficient (0.9994 and 0.9992 for DAS and PDH respectively) was found between the concentration range of 10-50 µg/ml for DAS and 5-25 µg/ml for PDH. The limit of detection for the method was 1.8 and 0.4 µg/ml for DAS and PDH respectively. The limit of quantification for the method was observed to be 4.4 and 4.2 µg/ml for DAS and PDH respectively The precision of the method was satisfactory; the values of relative standard deviations did not exceed 2%. The recovery values were 99.4-99.8% ± 1.61% for DAS and 99.8-100.4% ± 0.12% for PDH. The chromatographic method was developed on AGILENT HPLC with UV detection. The method was optimized by Kromosil-C₁₈, (250 * 4.6mm, 5μ) column by using phosphate buffer (pH_ 5)>: methanol (40:60) as a mobile phase with 1 ml/min as flow rate. The detection wavelength is 263 nm. The proposed method are successfully applied for the determination of DAS and PDH in bulk and their dosage forms. The method is having higher sensitivity and wider linear range. The proposed method is practical and valuable for its routine application in quality control laboratories for estimation of DAS and PDH.