A sensitive, accurate and precise method was developed and validated for the simultaneous estimation of doxylamine succinate and pyridoxine hydrochloride in its combined dosage form. The developed RP-HPLC method had shown adequate separation for doxylamine succinate and pyridoxine hydrochloride from its degradation products. The separation was achieved by using a C18 column (150 х 4.6 mm i.d.) with mobile phase composition of phosphate buffer pH 4.0 and acetonitrile (70:30) %v/v at a flow rate of 1 ml/min, with detection wavelength of 260 nm. The retention time for pyridoxine hydrochloride and doxylamine succinate were 2.400±0.5 min and 4.256±0.5 min. with linearity range 10-50 μg/ml. Proposed method was validated as per ICH guidelines for linearity, accuracy, precision, specificity and LOD and LOQ and found to be useful for estimation of doxylamine succinate and pyridoxine hydrochloride in its tablet dosage form.
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