Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC AND RP-HPLC METHODS FOR SIMULTANEOUS ESTIMATION OF LAMOTRIGINE AND BUPROPRION IN SYNTHETIC MIXTURE

Dhara Patel*, Mitali Dalwadi and Dr. Umesh Upadhyay

ABSTRACT

UV spectrophotometry method was developed for the simultaneous estimation of Lamotrigine (LAMO) and Bupropion (BUP) in Synthetic mixture. The method was developed to estimate and separate Lamotrigine (LAMO) and Bupropion (BUP) using first Order Derivative UV spectrophotometry developed method was validated as per ICH Q2 (R1) guideline. A Specific, precise, Accurate, Robust and cost-effective first Order Derivative UV spectrophotometry method was developed for simultaneous determination of Lamotrigine (LAMO) and Bupropion (BUP) in their synthetic mixture. Analytical RP-HPLC method was developed for the simultaneous estimation of Lamotrigine (LAMO) and Bupropion (BUP) in Synthetic mixture. The method was developed to estimate and separate Lamotrigine (LAMO) and Bupropion (BUP) using RP-HPLC and developed method was validated as per ICH Q2 (R1) guideline. A Specific, precise, accurate, robust and cost-effective Reversed Phase High Performance Liquid Chromatographic method was developed for simultaneous determination of Lamotrigine (LAMO) and Bupropion (BUP) in their synthetic mixture. For RP-HPLC the drugs were separated by Shimadzu P series integrated HPLC C18 Column (250 mm × 4.6 mm, 5 μm), utilizing a Mobile Phase Acetonitrile: Methanol: water (60:20:20 v/v/v) at Flow Rate of 1 ml/min, injection volume 10 μl with UV detection at 223 nm. The retention time of Lamotrigine (LAMO) 3.215 min and Bupropion (BUP) 9.119 min using RP-HPLC. The result of analysis was validated according to ICH Q2 R1 Guidelines. This simple and precise method can be used of both drug in quality control laboratories.

Keywords: UV Spectroscopy, First Derivative, Spectra, HPLC, Chromatography, Stationary Phase, Mobile Phase, Development, Validation parameters.