Abstract

METHOD DEVELOPMENT AND VALIDATION OF GABAPENTIN AND METHYLCOBALAMIN IN BULK AND FORMULATION BY HPLC

Shaik Karishma, *Karavadi Thejomoorthy, Ch. Saibabu

ABSTRACT

The aim of the present work was to develop and validate a simple, efficient, economical method for the estimation of Gabapentin and Methylcobalamin its in bulk and Pharmaceutical dosage forms by reverse phase high pressure liquid chromatography. Chromatography was performed on Inert Sustain swift -C18 (250 mm x 4.6 mm, 5 μm) with mobile phase containing a buffer of Potassium dihydrogen Phosphate, Sodium dihydrogen orthophosphate and 1-Butane Sulfonic acid sodium salt mixed with Acetonitrile and Methanol in the ratio 80:15:5 v/v/v at a flow rate of 1.0 mL/min and eluents were monitored at 205 nm. The retention times of Gabapentin and Methylcobalamin were 4.238 min and 10.539 and showed a good linearity in the concentration range of 750-4500 μg/mL for Gabapentin, 1.27-7.63 μg/mL for Methylcobalamin with a correlation coefficient of 0.9999 and 0.9998. The validation characteristics included specificity, linearity, precision, robustness and stability. Validation acceptance criteria were met in all cases. The percent recoveries ranged between 95-105 % RSD < 2%. The method could be successfully used for the analysis of Gabapentin and Methylcobalamin in bulk and pharmaceutical dosage forms.

Keywords: Gabapentin and Methylcobalamin, Formulation, Cleaning sample, UPLC, PDA.