Determination of Letrozole in Tablet Formulations by Reversed Phase High Performance Liquid Chromatography

Abstract

Purpose: To develop a simple, rapid, accurate and cost-effective reversed phase high performance liquid chromatography (RP-HPLC) method for letrozole in bulk and in tablets. Methods: Development of a method for the determination of letrozole, an anti-cancer drug, by RPHPLC was undertaken using a new mobile phase of acetonitrile:water (50:50, v/v). The eluent was monitored at 265 nm. Results: The optimized conditions developed showed a linear response from 160 to 240 μg/mL, with a correlation coefficient (R2) of 0.999. The limit of detection (LOD) and limit of quantification ( LOQ) were 136 and 160 μg/mL, respectively. The assay values for the two branded letrozole tablets tested were 99.2 and 100.2 %, respectively with % relative standard deviation (RSD) of 0.781 and 0.568, respectively. The bench top stability data of the drug in the mobile phase indicate that the drug was stable in the mobile phase for 24 h. Recovery data were good. Placebo study for specificity and interference of common excipients showed that the method was specific and free from interfering substances. Conclusion: Therefore, the fully validated method developed was sensitive enough to carry out routine analysis of letrozole in tablet formulations with regard to its run time, simplicity of sample preparation and accuracy.

Key words: Letrozole, Assay, HPLC, Validation, Tablet formulation.