Wed, 22 Nov 2017

Analytical Method Development and Validation for Estimation of Bosentan in Bulk and Tablet Dosage Form by High Performance Thin Layer Chromatography

S.H.Rizwan1*, V.Girija Sastry2 , Shaik Gazi1, Nikath Jahan1

1. Department of Pharmaceutical Analysis,Deccan School of Pharmacy, Hyderabad

2. Department of Pharmaceutical Chemistry, College of Pharmaceutical Sciences, Andhra University


ABSTRACT

A simple, sensitive and accurate method employing HPTLC has been developed and validated as per ICH guidelines for determination of Bosentan in bulk and Tablet dosage form. The absorption maxima of the drug were found to be 288 nm in methanol. The method was validated as per ICH guidelines. The linearity range was found to be 50-300 ng/ml with a regression coefficient of 0.98.Subsequent validation parameters like precision, repeatability in terms of Interday and Intraday precision and recovery studies were evaluated with satisfactory results, the % RSD for these parameters was found to be 1.73%,1.30-0.48%,1.80 – 0.45 % , 1.54 – 1.48 % respectively with an Rf value of 0.23.

Keywords: Bosentan, High Performance Thin Layer Chromatography, Validation


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