TY - JOUR AU - Annapurna, Dr. Mukthinuthalapati Mathrusri PY - 2022/12/15 Y2 - 2024/03/29 TI - A New Stability Indicating RP-UFLC Method for the Estimation of Letrozole in Presence of Internal Standard JF - Asian Journal of Pharmaceutics (AJP) JA - AJP VL - 16 IS - 4 SE - ORIGINAL ARTICLES DO - UR - http://www.asiapharmaceutics.info/index.php/ajp/article/view/4621 SP - AB - <p>Introduction: Letrozole is an anti-cancer agent especially used for the treatment of estrogen-dependent breast<br>cancers. A new stability indicating reversed-phase ultra-fast liquid chromatography (RP-UFLC) method has been<br>proposed for the estimation of Letrozole in tablet dosage forms. Materials and Methods: Shimadzu Model UFLC<br>system with PDA detector and Luna C8 column with mobile phase mixture methanol: Acetonitrile: 0.1% aq.<br>acetic acid (10: 40: 50) with flow rate 1.0 mL/min was chosen on isocratic mode (Detection wavelength 255 nm).<br>Results and Discussion: Letrozole obeys Beer–Lambert’s law over the concentration range 0.05–100 μg/mL with<br>linear regression equation y = 3679×–0.0002 (R² = 0.9999). The limit of quantification and limit of detection were<br>found to be 0.0158 μg/mL and 0.0484 μg/mL. Stress degradation studies were performed such as acid hydrolysis,<br>alkaline hydrolysis, thermal treatment, and oxidation and the method was validated as per ICH guidelines. The<br>proposed RP-UFLC method was applied for the quantification of pharmaceutical formulations (Tablets) and found<br>to be simple, precise, accurate, and robust. Conclusion: The proposed RP-UFLC method was applied for the<br>quantification of pharmaceutical formulations (Tablets) and found to be simple, precise, accurate, and robust.</p> ER -