Sat, 18 Nov 2017

Development and Validation of Stability Indicating High Performance Liquid Chromatographic Assay for Exemestane In Bulk

CH. Lakshmi Prasanna1*, A.Viswanath1,  P. Srinivasa Babu1

1. Department of Pharmaceutical Analysis and Quality Assurance, Vignan Pharmacy College, vadlam Udi, guntur-522213, Andhra Pradesh, India.


ABSTRACT

A simple reverse phase specific and selective high performance liquid chromatographic method for determination of Exemestane in Exemestane tablets has been developed and validated with Isocratic elution and UV detection. Chromatographic separation was achieved by using Hypersil, C-18, 150 X 4.6mm, 5µ column with a mixture of Acetonitrile and Purified water in the ratio of 35:65, filter and degas the mobile phase same is used as diluent. Detection was at 249 nm. By this method all known and unknown Impurity & Degradation products are well separated from Exemestane main peak.  Peak purity factor for Exemestane peak is not less than 99.0%. Both the Precision (System Precision, Method Precision, Intermediate Precision) and Linearity were within acceptable range. Response was a linear function between concentration and area of peak over the   range from 50% to 150% of assay concentration for Exemestane. It can be concluded that the Exemestane Peak is found to be degraded more in acid, alkali and peroxide stress condition. Exemestane Peak purity factor was more than 99.0% and all degradation product formed were well separated from Exemestane Peak. By this it was found that this method is robust and system suitability test was established and related parameters are recorded. This method is validated hence this method can be used for routine analysis of stability sample.

Keywords: High performance liquid chromatography, Exemestane, stability, Precision and peak purity.


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