HPTLC Method Development and Validation of Riluzole in Bulk and Pharmaceutical Dosage Form
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Abstract
Riluzole is used in the treatment for amyotrophic lateral sclerosis (ALS). The present work describes simple, precise and accurate HPTLC method for the determination of riluzole in bulk and its dosage form. Quantification of riluzole was carried out with Aluminum packed silica gel 60 F 254 precoated TLC plates as a stationary phase using a mixture of mobile phase consists of hexane: ethyl acetate in the ratio 1:1 v/v and in the absorbance/ reflectance mode at 222 nm using a CAMAG TLC scanner 3 with winCATS software version 1.4.3. The Rf value of riluzole was found to be 0.34 (±0.02). The proposed method has permitted the quantification of riluzole over the linearity range of 200-1000 ng/spot and its percentage recovery was found to 99.17%. The intraday and interday precisions were found to be 1.26% and 1.40%, respectively. The limit of
detection and the limit of quantification were found to be 18 ng/spot and 54 ng/spot respectively. The Coefficient of determination (r2) was 0.9992. The regression equation was found to be Y =9.8542C + 276.09. The accuracy and reliability of the proposed method was ascertained by evaluation various validation parameters like linearity, precision, accuracy and specificity according to ICH guidelines. The proposed method was analysed with more formulation units on a single plate and provided a faster and cost effective quality control tool for routine analysis of riluzole in bulk and its dosage form. The excipients in the commercial tablet preparation did n’t interfere in the method.
Keywords: Riluzole, ALS, HPTLC, densitometric evaluation, ICH guidelines, method development and validation
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