Abstract

ANALYTICAL METHOD DEVELOPMENT, OPTIMIZATION AND VALIDATION OF CARBAMAZEPINE DRUG BY USING RP – HPLC

Dr. Nimita Manocha, Jayshree Bagal*, Dr. Gurmeet Chhabra, Gyanendra Patel, Gaurav Sarsodia

ABSTRACT

This work aims to develop, improve, and validate a simple, accurate, precise, and environmentally friendly RP-HPLC method for measuring carbamazepine. A Waters C18 column, a mobile phase of methanol, triethylamine, formic acid, and water (40:60 v/v), a flow rate of 2.0 mL/min, and a detection wavelength of 230 nm were used to optimize the process. Carbamazepine's retention time was 2.501 minutes, with a notable peak. The accuracy, precision, linearity, specificity, and system suitability of the approach were all confirmed to be in compliance with ICH guidelines. As seen by the results, which showed good linearity (R2 = 0.999), robust recovery (99–100%), and acceptable percentage RSD values (<2%), the technique was robust and reliable. A cost-efficient and useful analytical tool for This study provides regular examination of carbamazepine.

Keywords: Method Development, Validation, ICH Guidelines, Accuracy, Precision, Specificity, Linearity, System Suitability, Carbamazepine, and RP-HPLC.