DEVELOPMENT & VALIDATION OF A RP-HPLC METHOD FOR THE ESTIMATION OF ACOTIAMIDE IN COMBINATION WITH AMITRIPTYLINE IN BULK AND PHARMACEUTICAL FORMULATION

Acotiamide and Amitriptyline prokinetic agent with gastrointestinal (GI) motility-enhancing activity. “Development and validation of RP-HPLC method for estimation of Acotiamide and Amitriptyline in Bulk Drug And it`s Dosage form” Attempts were made to develop RP-HPLC method for simultaneous estimation of Acotiamide and Amitriptyline from Tablet. For the RP - Agilent Tech. Gradient System with Auto injector, UV (DAD) & Gradient Detector Reverse Phase (Agilent) C18 column (4.6mm x 250mm;5µm), a 20µl injection loop and UV730D Absorbance detector and running chemstation 10.1 software.

Methanol: water (0.05%OPA), (90:10) v/v, pH 3.was used as the mobile phase for the method. The detection wavelength was 228 nm and flow rate was 0.7ml/min. In the developed method, the retention time of Acotiamide and Amitriptyline was found to be being 4.470 min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible.

So the proposed methods can be used for the routine quality control analysis Acotiamide and Amitriptyline in bulk drug as well as in formulations.

Keyword: Acotiamide, Amitriptyline, HPLC.