Abstract :
A simple, rapid and precise method is developed for the quantitative simultaneous determination of Doxylamine Succinate and Pyridoxine Hydrochloride in bulk and combined pharmaceutical dosage forms. The method was based on UV-Spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 257 nm (λmax of Doxylamine Succinate) and 324 nm (λmax of Pyridoxine Hydrochloride) in Methanol:water (70:30). For UV Spectrophotometric method, linearity was obtained in concentration range of 5-25 mcg/ml for Doxylamine Succinate and 5-25 mcg/ml for Pyridoxine Hydrochloride respectively, with regression 0.999 and 0.998 for Doxylamine Succinate and Pyridoxine Hydrochloride respectively. Recovery was in the range of 97 -103%; the value of standard deviation and %R.S.D were found to be < 2 %; shows the high precision of the method., in accordance with ICH guidelines. The method has been successively applied to bulk and pharmaceutical formulation and was validated according to ICH guidelines.
Keyword :
Doxylamine Succinate, Pyridoxine Hydrochloride, UV Spectrophotometer.