REVIEW ON THE ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY A NEW CHROMATOGRAPHIC METHOD FOR ANALYSIS OF PHARMACEUTICALS AND DRUG MOLECULES

Narla Mahendra Kumar* and Chennu M. M. Prasada Rao

ABSTRACT

Ultra Performance Liquid Chromatography (UPLC) methods, a systematic approach was taken in order to optimize the chromatographic conditions, including the selection of the UPLC column and the choice of mobile phase. Ammonium acetate buffer was chosen for its organic nature and wide pH range compatibility, with its pH being adjusted using formic acid to enhance resolution and make the mobile phase compatible with LC-MS. The flow rate, injection volume, and column oven temperature were optimized to achieve the required resolution and peak shape, ensuring effective separation and detection of impurities. Stress studies showed the stability-indicating characteristic of the developed method, specifically for the determination of gliclazide and its potential impurities in pharmaceutical dosage forms. The method was validated for system suitability, linearity, precision, specificity, accuracy, solution stability, filter interference, and robustness, meeting the criteria specified by the International Conference on Harmonization (ICH) guidelines. The developed UPLC method was demonstrated to be sensitive, precise, accurate, and stability-indicating, providing a comprehensive and specific approach for the analysis of pharmaceutical drugs and their impurities.

Keywords: Analysis of Pharmaceuticals, System suitability Method development, Accuracy and Precision, ICH Gridlines, RP-UPLC.