RP-HPLC Method Development and Validation of Pregabalin and Nortriptyline in Bulk and Pharmaceutical Dosage Form

Dr. Gampa Vijay Kumar¹, P. Sowjanya², D. Tejaswini^3
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
²KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
³KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

ABSTRACT
High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Pregabalin and Nortriptyline was done by RP-HPLC. The Phosphate buffer was p^H 4.5.and the mobile phase was optimized with consists of Phosphate buffer: Methanol P^H 4.5(20:80 v/v). Kromasil C18 (250mm x 4.6mm)5µg or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 254 nm. The solutions were chromatographed at a constant flow rate of 1ml min^-1. the linearity range of Pregabalin and Nortriptyline were found to be from 100-500 mg/ml of Pregabalin  and 1-5mg/ml of Nortriptyline . Linear regression coefficient was not more than 0.999.The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Pregabalin and Nortriptyline. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH and USP requirements .it inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.
Keywords:  Inertsil C_18, Pregabalin and Nortriptyline, RP-HPLC