Abstract

DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE AND FOLIC ACID IN THE COMBINED DOSAGE FORM

Rama Krishna V., Krishna Veni. P. R , Vijay K, Bala Murali Krishna K  andHari Babu B*

ABSTRACT

An isocratic, reversed phase-HPLC method was developed and validated for the quantitative determination of Doxylamine succinate and Pyridoxine hydrochloride and Folic acid in combined-dosage form. A Inertsil -ODS (250mmx4.6mm, particle size 5μm) column with mobile phase containing water (pH 5.2 adjusted with sodium acetate) and methanol in the ratio of 600: 400 v/v was used. The flow rate was 1.0 mL/min, column temperature was 25°C and effluents were monitored at 247 nm. The retention times of doxylamine succinate and pyridoxine hydrochloride and folic acid were 1.4 min and 2.2 min and 4.4 min respectively. The correlation co-efficient for Doxylamine succinate, Pyridoxine hydrochloride and Folic acid was found to be 0.99 , 0.99 and 0.99 respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of doxylamine succinate and pyridoxine hydrochloride and folic acid in formulations was found to be 100% , 100% and 100% respectively confirms the non-interferences of the excipients in the formulation. Due to its simplicity, rapidness and high precision. The method was successfully applied to the estimation of doxylamine succinate and pyridoxine hydrochloride and folic acid in combined dosage form.

Keywords: RP-HPLC, doxylamine succinate, Pyridoxine hydrochloride, Folic acid, estimation.