Statistical assurance of process validation by analytical method development and validation for efavirenz tablets and blend.
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Date
2010-08
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Abstract
A new simple, rapid and reliable UV Spectrophotometry method was developed
and validated for the estimation of Efavirenz in blend & Tablets formulations. The method was
based on simple UV estimation in cost effective manner for regular laboratory analysis. The
instrument used was Perkin Elmer, UV Spectrophotometer (Lambda 25) and using 0.1 N NaoH
as solvent system. Sample were analysed using UV Win Lab 5.2.0 Software and matched quartz
cells 1 cm and was monitored at 302 nm. Linearity was obtained in the concentration range of
2 - 10 mg mL–1 for Efavirenz. The validation parameters, tested in accordance with the
requirements of ICH guidelines, prove the suitability of this method. Spectrophotometric
interferences from the Tablets excipients were not found. The results of blend uniformity and
content uniformity, done on process validation batches samples.
Description
Keywords
UV Spectrophotometer, Efavirenz, Process Validation, Tablets Formulations, Quantitative analysis
Citation
Kumaraswamy D, Rao Rajasridhar,Rathinaraj B Stephen, Ch Rajveer, Sudharshini S. Statistical assurance of process validation by analytical method development and validation for efavirenz tablets and blend. International Journal of Applied Biology and Pharmaceutical Technology. 2010 Aug-Oct; 1(2): 399-403.