Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR THE DETERMINATION OF LETROZOLE IN BULK AND TABLET DOSAGE FORM

N. Tamilselvi*, R. Arivukkarasu, Ancymol Antony, Anitha T. J,, Boominathan A., Chandrasekar R., Deepthi Visakh

Abstract

Letrozole is a potent and selective non – steroidal Aromatase inhibitor approved for the use in post - menopausal woman who have breast cancer that has progressed after antiestrogen therapy.The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. The chromatographic separation was carried out on precoated silica gel 60F254 aluminium plates using mixture of chloroform : methanol (9:1 v/v) as mobile phase and densitometric evaluation of spots was carried out at 254 nm using Camag TLC Scanner-3 with win CAT 1.3.4 version software. The experimental parameters like band size of the spot applied, chamber saturation time, solvent front migration, slit width etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with Rf value 0.11±0.01. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (500-5500 ng/spot), precision (intra-day RSD 0.17-1.54%, inter-day RSD 0.30-1.43%), accuracy (99.3 to 99.8 %) and specificity according to ICH guidelines. The proposed method can analyze eight or more formulation units simultaneously on a single plate and provide a faster and cost-effective quality control tool for routine analysis of letrozole as bulk drug and in tablet formulation.

Keywords: Letrozole, HPTLC, densitometric estimation, method development and validation.