Development and Validation of a HPTLC Method for the Estimation of Lornoxicam in Bulk Drug and in Tablet Dosage Form

Abstract

Introduction : Lornoxicam is a selective cyclooxygenase-1 and 2 inhibitor that exhibit anti inflammatory, analgesic and anti pyretic activities. It is used in the management of osteoarthritis, rheumatoid arthritis, postoperative pain and primary dysmenorrhoea. Aim : The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. Methods : The chromatographic separation was carried out on precoated silica gel 60 GF254 aluminium plates using mixture of Tetrahydrofuran: Methanol:Ethyl acetate:Ammonia (2:1.5:5.5:0.6 v/v/v/v) as mobile phase and densitometric evaluation of spots was carried out at 377 nm using CAMAG TLC Scanner-3 with win CATS 1.4.1 version software. The experimental factors like band width of spot, chamber saturation time, slit width, solvent front migration etc. were critically studied and optimum conditions were developed. Results : The drug was satisfactorily resolved with Rf value 0.34 ± 0.01. The accuracy and reliability of the proposed method was determined by evaluating various validation parameters like linearity (100-1000 ng/band), precision (intra-day RSD 0.05-0.10 %, inter-day RSD 0.04-0.13%), accuracy (98.26–100.60%) and specificity according to ICH guidelines. The drug was also subjected to acid, alkali, oxidation, thermal and photochemical degradation studies and the method was found to be effective in separating the drugs from their degradation products. Conclusion : The proposed method is simple, accurate, precise and may be used as a cost-effective quality control tool for routine analysis of Lornoxicam as bulk drug and in tablet formulation. Key words : Densitometric estimation, HPTLC, Lornoxicam, Precision, Stability, Validation.