European Journal of Biomedical and Pharmaceutical Sciences

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING OF VARIOUS DRUGS BY USING RP- UPLC

Poojagolla Rajagopal, Harika Penmetsa and Raja Sundararajan*

ABSTRACT

The main requirement of pharmaceutical company is to reduce the fair in the development of new drugs to enhance sensitivity, specificity, robustness, resolution for their detection. This can be achieved by UPLC which is the modified HPLC method comprising high pressure and small sized particles (less than 2μm) used in the column. The review article reveals the method development and validation of stability indicating on various drugs by RP- UPLC. The different mobile phases like potassium di hydrogen, acetonitrile, sodium phosphate, methanol, sodium di hydrogen, trifluoro aceticacid, and ammonium acetate buffer were used in RP-UPLC. The chromatographic separation was carried by different stationary phases like C18, X-terra RP18, Acquity UPLC BEHRP-18, Kromasil Eternity TM C 18, Acquity® HSS-T3, Zorbax SB-C18 which are processed by using isocratic method. The validation method was evaluated with various parameters like linearity, precision, accuracy, robustness, LOD and LOQ. The evaluation of stability of drugs was performed with various degradation parameters such as oxidation, hydrolysis, acid base hydrolysis and photolytic hydrolysis. From the review, it was observed that C18 column was efficient for the separation due to the smaller particles size provides better resolution and retention time. The different mobile phases like like potassium di hydrogen, acetonitrile, sodium phosphate, methanol, sodium di hydrogen, trifluoro acetic acid and ammonium acetate were generally favors for the effective separation and yields good retention time. All varied parameters were validated as per ICH guidelines and report shown within the limits. Similarly, it was revealed that some drugs were shown stability and mild degradation. The developed method by RP-UPLC was validated per the ICH guidelines and found to be specific, precise, accurate and linear. Hence, the review was clearly indicated that UPLC method is possible to develop a new sensitive and accurate for different pharmaceutical formulations.

Keywords: Method development, Ultra pressure liquid chromatography, Column temperature, High pressure liquid chromatography, Photodiode array.