DEVELOPMENT AND VALIDATION FOR THE ANALYSIS OF OLAPARIB IN API FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

Thirivenis P. Arun Kumar*, G. Anuhya Goud, Dr. Yasodha and Allakonda Rajamani

ABSTRACT

An analytical, new, simple, rapid, robust, precise, accurate and reproducible RP-HPLC method for estimation of Olaparib in bulk form and marketed formulation. Separation of Olaparib was successfully achieved on a Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol : Phosphate buffer (0.02M, pH-3.6) in the ratio of 45:55% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 12-28mcg/mL for Olaparib. The correlation coefficient was found to be 0.9995 for Olaparib. The LOD and LOQ for Olaparib were found to be 5.004μg/mL and 15.164μg/mL respectively. The proposed method was found to be good percentage recovery for Olaparib, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

Keywords: Olaparib, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.