Stability Indicating RP-HPLC Method for Simultaneous Estimation of Amitriptyline Hydrochloride and Pregabalin in Bulk and Pharmaceutical Dosage Form

K. Suma, Rameeja Pattan^*, V. Hari Baskar, Ramesh Dhani
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore.

ABSTRACT
A simple, accurate ,precise method was developed for the simultaneous estimation of the amitriptyline hydrochloride and pregabalin  in tablet dosage form .chromatogram was run through ODS (250MM 4.6mm,5µ).Mobile phase containing potassium dihydrogen ortho phosphate as buffer and acetonitrile  in the ratio of 50:50 was pumped through coloum at a flow rate of 1ml\min maintaining the ph to 3. Temperature was maintained at 25⁰C. Optimized wavelength for pregabalin and amitriptyline hydrochloride was 210nm. Retention time of pregabalin was found to be 2.4min and 4.1min.percentage RSD values of pregabalin and amitriptyline hydrochloride were 0.6 and 0.4 respectively. Percentage recover was obtained as 99.34 and 99.93 for pregabalin and amitriptyline hydrochloride respectively. LOD, LOQ values of pregabalin and amitriptyline hydrochloride were 3, 9.98, 2.98 and 10 respectively. Accuracy, precision, ruggedness ,robustness values were followed as per ICH guidelines.
Keywords: Inertsil ODS column, Amitriptyline hydrochloride and pregabalin RP-HPLC