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A novel high resolution RP-UPLC method for the quantitative determination of exemestane and its related compounds

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Author(s): Maheswara Reddy Musirike1, K. Hussain Reddy1, Ramkumar Dhandapani2, Useni Reddy Mallu1 and Varaprasad Bobbarala3*.

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 2;
Start page: 546;
Date: 2011;
Original page

Keywords: Exemestane | Ultra performance liquid chromatography | breast cancer | method development and validation.

ABSTRACT
Exemestane is used in the treatment of breast cancer such as hormone-receptor-positive breast cancer in women after menopause stage. A novel high resolution, less runtime, reproducible and accurate RP-UPLC method was developed for the quantification of related compounds in Exemestane drug substance. The separation of Exemestane and its four related compounds was achieved on a high strength silica (HSS) T3 UPLC column by a simple gradient program. Mobile phase was composed of sol-A: water and sol-B: acetonitrile (Time/percent of sol-B: 0/40, 4.4/60, 4.6/40, 6.0/40) with 0.5ml per min flow rate. UVdetection was done at 250nm. The developed method was validated as per ICH guidelines with respect to precision, accuracy, specificity, robustness, limit of detection and limit of quantification.
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