A simple, precise and accurate reverse phase high performance liquid chromatography method for analysis of amitriptyline hydrochloride and methylcobalamin in tablet dosage form was developed and validated according to ICH guidelines. The quantification of the drug was carried out by using Hibar® C18 (250 X 4.6 mm, 5 μ) column and maintain column at 20°C, using mobile phase comprising of Dibasic sodium phosphate buffer: Methanol in the ratio of 70:30 % v/v (Adjust pH-6 with orthophosphoric acid), with a flow rate of 1.0 ml/min and the detection wavelength was carried at 218 nm. The retention time for amitriptyline hydrochloride and methylcobalamin was found to be 2.300 and 3.340. The content uniformity was found to be 98.69-101.58% and 98.99-102.42%. Proposed method was validated for precision, accuracy, linearity and range, specificity and robustness according to ICH Q2R1 guidelines. The method was successfully applied to amitriptyline hydrochloride and methylcobalamin their tablet dosage form.
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