DEVELOPMENT AND VALIDATION OF NOVEL STABILITY INDICATING RP-HPLC METHOD FOR QUANTIFICATION OF ALIMEMAZINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

Specific stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for the quantification of alimemazine in bulk drug and pharmaceutical dosage forms. Chromatographic separation was done on C 18 column (250 mm X 4.6 mm X 5 µm) using a mobile phase containing a mixture of methanol: 0.02 M potassium dihydrogen orthophosphate buffer in the ratio 75:25 V/V (pH was maintained at 3.0 by using o-phosphoric acid) on isocratic mode at flow rate of 1.0 mL min-1 and detection wavelength of 257 nm. The retention time of alimemazine was found to be 4.528 min with linearity in the concentration range from 10 – 50 µg mL-1. The mean percentage recovery of alimemazine was found to be 99.3 – 100.62 %. The percent relative standard values were less than 2.0 % at all the levels, indicating a satisfactory accuracy and precision of the method. Performed robustness study was found to meet the acceptance criteria. In order to check the selectivity of the proposed method, degradation studies were carried out using hydrolysis (acid and alkali), oxidation, photolytic and thermal degradation conditions. The developed method, after being validated in terms of precision, accuracy, LOD, LOQ and robustness was successively applied to the analysis of pharmaceutical formulation.