Abstract

ANALYTICAL METHOD DEVELOPEMENT AND VALIDATION FOR ESTIMATION OF LOBEGLITAZONE SULFATE IN PHARMACEUTICAL DOSAGE FORMS BY UV SPECTROPHOTOMETRIC METHOD

C. A. Shaik Fayaaz Ahamed*, M. Sathish, B. Sarumathy, M. Seenuvasan, E. Shuruthiga and E. S. Sharma

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Abstract

The developed UV-Visible spectroscopy method for analyzing lobeglitazone sulfate tablet formulation is simple, rapid, accurate, precise, and sensitive. The method has been validated, with n-butanol used as the solvent. All validation parameters, including linearity, precision, accuracy, and robustness, showed less than 2% RSD, in accordance with ICH guidelines, indicating the method's sensitivity. The correlation coefficient was 0.998. Both intra-day and inter-day %RSD values were within the acceptable range, and accuracy remained within normal limits. The method's limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.231 μg/mL and 1.015 μg/mL, respectively, demonstrating its suitability for the rapid quantification of lobeglitazone sulfate. In conclusion, the proposed method is accurate, precise, reliable, and compliant with ICH guidelines, making it ideal for routine analysis of lobeglitazone sulfate in bulk formulations.

Keywords: Lobeglitazone Sulfate, UV-Visible Spectroscopy, Validation.