Method Development and Validation for Estimation of Anastrozole in Pharmaceutical Dosage Form by RP-HPLC

Abstract HPLC (LC-2010-HT, Shimadzu, Singapore) method for analysis of Anastrozole was carried out by the C-18 column (Inertsil, ODS 3V, 250mm X 4.6mm; 5µ) using a mobile phase consisting of buffer-acetonitrile (1:1) with the pH 2.5 adjusted by using buffer. 0.02 M KH2PO4. The mobile phase was pumped at the rate of 1.1 ml/ min and the detection was carried out at 233 nm. The linearity was found in the range of 10-30 µg/mL hence 20µg/mL was selected as optimum working concentration for the assay of Anastrozole with regression coefficient (r2> 0.99). The peaks obtained were sharp having clear baseline separation with a retention time of 7.1 minute for Anastrozole. The optimized method is precise, accurate and robust and so it can be applied as stability indicating for the estimation of Anastrozole in tablet dosage form.

Keywords Anastrozole, method development, linearity, regression coefficient, HPLC, validation.

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Updated: January 20, 2024 — 7:35 am