RP-HPLC METHOD DEVELOPMENT FOR THE SIMULTANEOUS ESTIMATION OF NIRAPARIB AND ABIRATERONE ACETATE IN PHARMACEUTICAL DOSAGE FORM

Shoaib Ahmed*, Dr. Anju Goyal

ABSTRACT

A new RP-HPLC method was established for simultaneous estimation of Niraparib and abiraterone acetate. The chromatographic conditions were successfully developed for the separation of Niraparib and abiraterone acetate. The analytical method was developed by studying different parameters. First of all, maximum absorbance was found to be at 250nm and the peak purity was excellent. Injection volume was selected to be 10µl which gave a good peak area. The column used for study was C18, ambient temperature was found to be suitable for the nature of drug solution. The flow rate was fixed at 1.0 ml/min because of good peak area and satisfactory retention time. Mobile phase Acetonitrile: Water (70:30% v/v) was fixed due to good symmetrical peak. So this mobile phase was used for the proposed study. Run time was selected to be 10min because analyze gave peak around 2.073, 5.052 ±0.02min respectively and also to reduce the total run time. The percent recovery was found to be 98.0-102 was linear and precise over the same range. Both system and method precision were found to be accurate and well within range. The analytical method was found linearity over the range 5-50µg/ml of Niraparib and 30-230 µg/ml of Abiraterone of the target concentration. Relative standard deviation was well satisfactory. Hence the suggested RP-HPLC method can be used for routine analysis of Niraparib and abiraterone acetate in API and Pharmaceutical dosage form.

Keywords: Niraparib, abiraterone acetate, simultaneous estimation, linearity, SD, RSD.