Stability Indicating RP-HPLC-PDA Method for Simultameous Quantification of Glucosamine, Methyl Sulphonyl Methane and Diacerein Tablets

摘要

A simple, fast, accurate and specific RP-HPLC-PDA method has been developed for the simultaneous quantification of, glucosamine, diacerein and methyl sulphonyl methane and in bulk and tablet dosage form. The chromatographic separation was performed on a reverse phase Altima C18 Column (150x4.6mm, 5mum particle size) consisting mobile phase of potassium dihydrogen ortho phosphate buffer: acetonitrile (65:35 v/v), with a flow rate 1ml/min, temperature 30°C and UV detection wavelength 254nm. The retention times of glucosamine, diacerein and methyl sulphonyl methane were observed as 2.13min, 3.48min and 4.16 min respectively. The developed method was validated by validation parameters such as linearity, range, accuracy, precision and robustness. The results obtained for validation parameters are within the limits as per ICH guidelines. The linearity of the drugs were obtained in the range of 37.5 ppm-225 ppm for Glucosamine, 12.5 ppm -75 ppm methyl sulphonyl methane and 2.5 ppm -15 ppm for diacerein. %RSD from precision studies were 0.8, 0.6 and 0.8, mean percentage recovery from accuracy studies were found to be 99.53%, 99.83% and 100.09% for Glucosamine, methyl sulphonyl methane and diacerein, respectively. LOD, LOQ values obtained from regression equations of Glucosamine, Methyl sulfonyl methane and diacerein were 0.47ppm, 0.53ppm, 0.14ppm, and 1.42ppm 1.60ppm, 0.41ppm respectively. The method designed and validated can be successfully used for the regular quantification of Glucosamine, Methyl sulfonyl methane and diacerein in tablet and bulk forms.