ABSTRACT

High Performance Liquid Chromatography (HPLC) is one mode of chromatography, one of the most used analytical techniques. Letrozole is indicated to treat postmenopausal women with hormone receptor (HR) positive early breast cancer, postmenopausal women with early breast cancer who have previously been treated with tamoxifen, and postmenopausal women with HR+ or unknown advanced breast cancer. Letrozole, given with Ribociclib, is indicated to treat pre and postmenopausal women with HR+ and human epidermal growth factor 2 (HER2) negative advanced or metastatic breast cancer. The present aim of the study is to development of Letrozole and Ribociclib HPLC method and validation of the test substance. The estimation of Letrozole and Ribociclib was done by RP-HPLC. The assay of Letrozole and Ribociclib was performed with tablets and the % assay was found to be 98.29 and 99.55 which shows that the method is useful for routine analysis. The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions. Keywords: Assay, Chromatography, Letrozole, Limit, Ribociclib
Publication date: 01/02/2025

https://ijbpas.com/pdf/2025/February/MS_IJBPAS_2025_8639.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.2.8639