STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LOBEGLITAZONE SULFATE AND GLIMEPIRIDE IN BULK AND TABLET DOSAGE BY UV SPECTROPHOTOMETRIC METHOD
*Nithya V., Murugan S. and Vetrichelvan T.
ABSTRACT
UV-spectrophotometric methods have been developed and validated for the Simultaneous estimation of Lobeglitazone sulfate (LOBE) and Glimepiride (GLIM) in combined dosage form. In the simultaneous equation method LOBE and GLIM have absorbance maxima at 251nm and 228 nm respectively in methanol. The method involves First order derivative spectroscopy using 265 nm and 241 nm as zero crossing points for LOBE and GLIM respectively. Linearity was observed in the concentration range of LOBE is 2-10 µg/ml and GLIM is 4-20 µg/ml for Simultaneous equation method and first order derivative method the concentration range of LOBE is 3-15 µg/ml and GLIM is 6-30 µg/ml The correlation coefficient was found to be 0.9998 for LOBE and 0.9997 for GLIM for Simultaneous equation method and 0.9998 for LOBE and 0.9998 for GLIM for First order derivative method, respectively. The precision (intraday, inter day) of methods was found within limits (RSD < 2%). Method showed good reproducibility and recovery with % RSD less than 2%. The samples of LOBE and GLIM were subjected to stress conditions like acidic, alkaline, oxidation, photolysis degradation. It could be concluded from the results obtained in the present investigation that the methods for simultaneous estimation of LOBE and GLIM in bulk and tablet dosage form are simple, rapid, accurate, precise and economical and can be used, successfully, in the quality control of tablet formulations and other routine laboratory analysis and the stability studies were successfully applied as per ICH guidelines.
Keywords: Lobeglitazone sulfate, Glimepiride, Simultaneous equation method, first order derivative method, Forced degradation studies.
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