Quantitative estimation of doxylamine succinate by zero-order derivative area under curve Spectrophotometric methods in bulk and in-tablet dosage form

The purpose of this study is to establish Zero-order UV-Spectrophotometric - absorbance and Zero Order- Area under curve (AUC) methods for estimation of Doxylamine succinate in bulk and in pharmaceutical dosage form . Doxylamine succinate is Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in parkinsonism, distilled water was used as solvent for solubilization of Doxylamine succinate. Maximum absorption for Doxylamine succinate was found to be at wavelength 260nm when dissolved in Distilled water. The methods are based upon measurement of absorbance at 260nm and integration of area under curve for analysis of Doxylamine succinate in the wavelength range of 251.20-267.20 nm. The drug followed linearity in the concentration range of 10 - 60µg/mL with correlation coefficient value r> 0.99 . The proposed methods were validated for accuracy (% recovery), precision, repeatability and ruggedness, as per ICH guidelines. The proposed methods were applied for qualitative and quantitative estimation of Doxylamine succinate in tablet and results were found in good agreement with the label claimed. Developed methods can be used for routine analysis of Doxylamine succinate in bulk and pharmaceutical tablet.