.

ISSN 2063-5346
For urgent queries please contact : +918130348310

METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF PREGABALIN BY USING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY IN API SUBSTANCE AND MARKETED PHARMACEUTICAL DOSAGE FORM

Main Article Content

Bipasha Behera1*, Uma Shankar Mishra2 and Sudhir Kumar Sahoo3
» doi: 10.48047/ecb/2023.12.si5a.0238

Abstract

The objective of this study was to develop a simple, sensitive and reproducible method for estimation of Pregabalin by Ultra Performance Liquid Chromatography (UPLC). Pregabalin was separated on Endeversil C18 ODS (2.1 x 50mm, 3µm), using 0.1% Octane Sulphonic acid buffer with pH of 3.0: Acetonitrile (30:70) at the PDA detection of 226nm. Isocratic elution of buffer and acetonitrile was used as a mobile phase with different flow rates, eventually 30:70 v/v buffer and acetonitrile was being set with the flow rate of 0.2 ml per min. Pregabalin was eluted at a run time of 2 mins. The statistical validation parameters such as linearity, accuracy, precision, inter-day and intra-day variation were checked as suggested by ICH recommendations, further the limit of detection and limit of quantification of Pregabalin concentrations were found to be 2.98µg/mL and 9.97µg/mL. Recovery and assay studies of Pregabalin were within 99 to 102% indicating that the proposed method can be adoptable for quality control analysis of Pregabalin in bulk form and Marketed Pharmaceutical dosage form.

Article Details