Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

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

Mani Ganesh^1,2 , Krishanan Rajasekar², Margandan Bhagiyalakshmi¹, Mari Vinoba³, Kavimani Saktimanigandan⁴, Hyun Tae Jang¹

¹Department of Chemical Engineering, Hanseo University, Season 360-706, South Korea; ²Department of Nanotechnology, Biotechnology Centre, Anna University Coimbatore, Jothipuram, Coimbatore 641-047, India; ³Carbon Dioxide Reduction & Sequestration Research Center, Korea Institute of Energy Research, Deajon, 305-343, Korea; ⁴Alkem Lab Ltd, Taloja-410208, Navi Mumbai, Maharashtra, India.

For correspondence:- Mani Ganesh Email: htjang@hanseo.ac.kr

Received: 17 April 2010 Accepted: 30 August 2010 Published: 17 October 2010

Citation: Ganesh M, Rajasekar K, Bhagiyalakshmi M, Vinoba M, Saktimanigandan K, Jang HT. Determination of Letrozole in Tablet Formulations by Reversed Phase High Performance Liquid Chromatography. Trop J Pharm Res 2010; 9(5):505-510 doi: 10.4314/tjpr.v9i5.12

© 2010 The authors.
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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 RP-HPLC 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.

Keywords: Letrozole, Assay, HPLC, Validation, Tablet formulation