Abstract

Development and validation of a RP-HPLC method for the determination of anastrazole in rat plasma by liquid-liquid extraction

Author(s): V. D. Sundar, R.Vijayalakshmi, V. S. H. Naveena and M. D. Dhanaraju*

Anastrazole is non-steroidal aromatase-inhibiting drug used for the treatment of breast cancer after surgery and metastasis in both pre and post-menopausal women. It acts by binding reversibly to the aromatase enzyme, inhibits the conversion of androgens to estrogens in peripheral tissues. Since HPLC methods were more accurate, precise and sensitive, the present work describes a simple, precise and accurate analytical HPLC method for the estimation of anastrazole in pure and tablet dosage form. The separation was carried out using phenomenex C18 (250 x 4.6 mm, 5 μm particle size) column, with a mobile phase consisting of acetonitrile and phosphate buffer (7.2) in the ratio of 80:20%, v/v. The flow rate was set at 0.9 ml/min and detection was monitored at 214 nm. The retention time of anastrazole is 3.3 min with linearity coefficient of 0.9999 and percentage recovery of 99.79. The linearity was found in the concentration range of 100-400 μg/ml for anasrazole. The proposed HPLC method was extended for the estimation of anastrazole in rat plasma. Anastrazole in spiked rat plasma was extracted with Ethyl acetate by liquid- liquid extraction procedure.The liquid chromatography method was extensively validated for linearity, accuracy, precision, and robustness. All these analytical validation parameters were observed and the %RSD was determined which indicates the usefulness of method for determination of anastrazole in formulation.

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