¹Department of Pharmacy, Y.B Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Rauza bag, Aurangabad 431001, Maharashtra, India
²Department of Pharmacy, Y.B Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Rauza bag, Aurangabad 431001, Maharashtra, India DOI : 10.29228/jrp.139 A sensitive, simple, rapid, stability-indicating reverse-phase high-pressure liquid chromatographic method was developed for the estimation of letrozole in solid lipid nanoparticles. The developed method was validated as per the International Council of Harmonization (ICH guideline) concerning system suitability, linearity, accuracy, precision, specificity, robustness, and range. The chromatographic separation was achieved on the Zorbax C18 column (250 x 4.6 mm ID; 5.0 μm particle size). Isocratic elution was performed using methanol: 0.1% orthophosphoric acid (60:40) at 0.7 mL/min flow rate. The detection was done using a UV-Vis detector at 240 nm. Linearity for the analytical method was observed at the concentration range of 10 to 50 μg/mL having a correlation coefficient of 0.999. The method was precise, accurate with a relative standard deviation (RSD) ≤ 2.0. The developed validated analytical method can be used as a quality control tool for the quantitative estimation of letrozole in a novel formulated solid lipid nanoparticle. Keywords : Letrozole; RP-HPLC; Solid lipid nanoparticle; ICH; Validation