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Development and validation of stability indicating reverse phase high performance liquid chromatography method for timolol maleate
Umesh Laddha D., Rohan Barse K., Rasika Zilpelwar V.,
Published in Sphinx Knowledge House
2014
Volume: 6
   
Issue: 5
Pages: 1429 - 1435
Abstract
A simple, economic, accurate and precise stability indicating method for Timolol Maleate was developed as per ICH guidelines Q1A(R2) and subsequently validated as per ICH guidelines Q2R(1). Chromatographic evaluation was carried out on C18 column of Kromasil (250 mm × 4. 6 mm, 5$\mu$m particle size) with a mobile phase consist of phosphate buffer: methanol (60:40 v/v). The pH of buffer was maintained to 3. 5 by using O-phosphoric acid. Flow rate was maintained to 1ml/min. Timolol Maleate was found to be stable in all conditions except in alkaline condition. In alkaline condition two degradation products were observed. Method was validated for different parameters like Linearity (calibration curve), accuracy, precision, robustness, recovery study. LOD and LOQ was found to be 0. 724 and 2. 19$\mu$g/ml respectively. The optimized and validated method can be used for estimation of Timolol Maleate in bulk and also in finished product.
About the journal
JournalInternational Journal of PharmTech Research
PublisherSphinx Knowledge House
ISSN09744304
Open AccessNo