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Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF ANASTROZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Sunitha Pasupuleti1*, Pillamari Ragamai and Merugu Mahesh

ABSTRACT

A new simple, precise, reliable, specific and accurate Reverse phase high performance liquid chromatography method was developed for estimation of Anastrozole in bulk and in it’s tablet dosage form was carried out on a Symmetry C18, 5μm, 25cmx4.6mm i.d. column using a mixture of Acetonitrile: Phosphate buffer pH-3.0 in the ratio of 75:25v/v as the mobile phase maintained at a flow rate of 1.0ml/min, the detection was carried out at 223nm. The retention time of the Anastrozole was 4.001minutes. The method produced linear responses in the concentration range of 0-70μg/ml of Anastrozole. The percentage recovery of the Anastrozole was found to be within the limits. The correlation coefficient of Anastrozole was found to be 0.999. The method precision for the determination of assay was below 2.0% RSD. The LOD values for Anastrozole were found 0.16μg/ml. The LOQ values for Anastrozole were found 1.64μg/ml. The method was validated for system suitability, specificity, linearity, accuracy, precision, ruggedness and robustness as per ICH guidelines and the results were found to be within the limits. The proposed method is suitable for the routine quality control analysis of Anastrozole in bulk and tablet dosage form.

Keywords: Anastrozole, Method Development, Validation, ICH Guidelines, Accuracy.


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