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

Abstract

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.