Stability Indicating HPLC Method Development ...

Stability Indicating HPLC Method Development and Validation for Simultaneous Estimation of Pregabalin, Mecobalamin and Nortriptyline HCL in Pharmaceutical Dosage Form

Author Name : Kurm Kshatriya Shweta Singh, Ms. Vanita Marvaniya, Mr. Nishith Patel, Dr Chaitnaya Bhatt

ABSTRACT

A Stability Indicating High Performance Liquid Chromatographic Method was developed for Simultaneous Estimation of Pregabalin, Mecobalamin and Nortriptyline HCl in Pharmaceutical Dosage Form. The separation was achieved by Cosmosil C₁₈ (250 x 4.6 mm, 5µ) Column And 0.02 M Ammonium Acetate Buffer: Acetonitrile (70:30) as Mobile Phase, at a flow rate of 1.0 ml/min. Detection was carried out at 295 nm, injection volume was 20μl and run time was observed to be 20 minutes. The Retention time of Pregabalin, Mecobalamin and Nortriptyline HCl were found to respectively 14.407, 9.200 and 11.190 minutes. Stability data of formulation is good and  developed HPLC method performed as per ICH Guideline. The aim of the present study is to develop sensitive, simple, rapid, economical, precise and accurate derivative spectrophotometric method with force degradation to determine Pregabalin, Mecobalamin and Nortriptyline HCl in Pharmaceutical dosage form present in a marketed tablet formulation. It can be successfully adopted for routine quality control analysis of Pregabalin, Mecobalamin and Nortriptyline HCl in combine dosage form without any interference from common excipients and impurity.

Keywords: Pregabalin, Mecobalamin, Nortriptyline HCl, HPLC Method, Stability, Validation.