Statistical assurance of process validation by analytical method development and validation for efavirenz tablets and blend.

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dc.contributor.authorKumaraswamy, D
dc.contributor.authorRao, Rajasridhar
dc.contributor.authorRathinaraj, B Stephen
dc.contributor.authorCh., Rajveer
dc.contributor.authorSudharshini, S
dc.date.accessioned2015-06-19T05:25:26Z
dc.date.available2015-06-19T05:25:26Z
dc.date.issued2010-08
dc.description.abstractA 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.en_US
dc.identifier.citationKumaraswamy 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.en_US
dc.identifier.issn0976-4550
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/158103
dc.language.isoenen_US
dc.source.urihttps://www.ijabpt.com/pdf/3125-Rajasridhar%20IJPPB.pdfen_US
dc.subjectUV Spectrophotometeren_US
dc.subjectEfavirenzen_US
dc.subjectProcess Validationen_US
dc.subjectTablets Formulationsen_US
dc.subjectQuantitative analysisen_US
dc.titleStatistical assurance of process validation by analytical method development and validation for efavirenz tablets and blend.en_US
dc.typeArticleen_US
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