European Journal of Biomedical and Pharmaceutical Sciences

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF DIFFERENT DRUGS BY RP-UPLC METHOD

Harika Penmetsa, Poojagolla Rajagopal and Raja Sundararajan*

ABSTRACT

UPLC chromatographic system is designed in a special way to withstand high system backpressures. This review introduce and summarize some of the most recent research works in the UPLC field. The different mobile phases like ammonium acetate buffer: methanol, phosphate buffer: acetonitrile, water: acetonitrile, potassium dihydrogen phosphate: acetonitrile, trifluro acetic acid: acetonitrile, phosphate buffer: acetonitrile and ortho phosphoric acid: methanol were commonly used for separation in UPLC analysis. Different columns like BEH C 18, HSS-T3, SB 18, Shimpak XR ODS and BEH shield RP 18 were utilized as stationary phases for chromatographic separation. The diverse parameters like specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness and robustness were analyzed. Further, the forced degradation study was also carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability indicating capability of the developed UPLC method. In the result analysis, the most efficiently mobile phases are ortho phosphoric acid: methanol, water: acetonitrile and phosphate buffer: acetonitrile. BEH C18 column was one of simplest and most convenient stationary phase used for RP-UPLC. All diverse parameters were validated as per ICH guidelines and report shown within the limits. The narrow peaks produced by fast UPLC require a small detection volume and fast acquisition rate to ensure high efficiency. UPLC is a simple, precise, accurate and selective method.

Keywords: Ultra performance liquid chromatography, Stability study, Method development, Drug analysis, Validation.