Abstract

HPLC METHOD FOR ESTIMATION OF LETROZOLE IN PHARMACEUTICAL FORMULATION. APPLICATION TO CONTENT UNIFORMITY TESTING

Nief Rahman Ahmed*, Suhaib Naeyf Lottfie and Yasmin Salim Hassan

ABSTRACT

A simple, precise, rapid, and accurate reversed – phase high performance liquid chromatographic method has been developed for the determination of Letrozole in pure from and pharmaceutical formulations. Chromatography was carried out on RP8 Macherge Nagel (L7 reversed- phase column (150mm × 4.6mm), 5 microns, using a mixture of water: Acetonitrile (530: 470 v/v) and pH adjusted to 2.5 with dilute phosphoric acid as a mobile phase at a flow rate of 1.0 ml.min-1. Detection was performed at 230nm at ambient temperature. The retention time for Letrozole was found 5.7 minutes. The calibration curve was linear (r= 0.999) over a concentration range from2.5 to 50 μg/ml. Limit of detection (LOD) and limit of quantitation (LOQ) were found 1.16ng/ml and 3.84ng/ml respectively. High performance liquid chromatography (HPLC) can be used for determination of drugs and for purposes of control throughout the entire manufacturing process of drugs. as well as quality control of the finished product It has the advantages of being sensitive, selective, rapid, accurate and reproducible. The proposed method was validated for its linearity, precision and accuracy which proves suitability for the routine analysis of Letrozole in true samples. The proposed method was successfully applied for the determination of Letrozole in tablets, application to content uniformity testing.

Keywords: HPLC, Letrozole, pharmaceutical formulations, Content uniformity testing.