Analytical Method Development and Validation of Simultaneous Estimation of Diacerein, Glucosamine and Methyl Sulfonyl Methane By RP-HPLC In Pharmaceutical Tablet Dosage Forms
Journal Title: IOSR Journal of Applied Chemistry (IOSR-JAC) - Year 2018, Vol 11, Issue 2
Abstract
A simple, Precise, Rapid, Specific and accurate reverse phase high performance liquid chromatography method was developed for the simultaneous estimation of Diacerein, Glucosamine and Methyl Sulfonyl Methane in drug product. A chromatographic method was scrutinized on Ascentis express C18 (100×4.6mm, 2.7µ) column and a mobile phase consists of Acetonitrile: Potassium dihydrogen orthophosphate and one drop of triethyl amine in every 100ml of buffer solution pH :3.0 (50:50%v/v). The flow rate was 1.0 ml/min with UV detection at 210nm. The retention time (Rt) of Diacerein, Glucosamine and Methyl Sulfonyl Methane were found to be 2.586, 3.182 and 4.469min respectively. As per ICH guidelines the developed method was validated in terms of specificity, Linearity, Accuracy, Precision, LOD, LOQ and robustness. All the parameters were found to be with in the limit. The linearity for Diacerein was in the range of 2.5 to 15 ppm, Glucosamine was in the range of 37.5 to 225 ppm and Methyl Sulfonyl Methane was in the range of 12.5 to 75 ppm. HPLC method was simple, Accurate, Precise and suitable for analysis of marketed tablet formulation containing Diacerein, Glucosamine and Methyl Sulfonyl Methane.
Authors and Affiliations
J. Sandya Rani, N. Devanna
Keywords
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- EP ID EP413978
- DOI 10.9790/5736-1102024754.
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