This study presents the development and validation of a UV spectrophotometric method for the
estimation of lobeglitazone in bulk and pharmaceutical formulations by QbD (central composite
design). Lobeglitazone, a potent anti-diabetic agent, was analyzed using UV spectroscopy due to its
simplicity, cost-effectiveness, and widespread availability. Till date, there is no UV-visible
spectrophotometric method reported using the AQbD approach. The method was optimized by selecting
methanol as solvent, wavelength 240nm and 1.134 of maximum absorption. Validation parameters such
as linearity, precision, accuracy, ruggedness, and robustness were evaluated according to ICH
guidelines. The method exhibited good precision over the concentration range, with correlation
coefficient values are less than 2%. The LOQ and LOD of the established method were found to be
0.83?g/ml, 0.70?g/ml and 2.54?g/ml,2.14 ?g/ml. The measured linearity of the calibration curve
ranges from 2 ?g/ml to 14 ?g/ml, with a R² of 0.997. %RSD of system suitability, inter-day and intra-
day precision value of 0.11&0.14% respectively. Accuracy, with Mean recovery was found to be
100,99.6,99.2 respectively for 50,100 & 150% with their %RSD values being 1.04-0.39. The robustness
was evaluated for change in wavelength and results were found to be 0.17&0.23 respectively. The
%RSD for ruggedness were found to be 0.26&0.18. Overall, the development of UV spectrophotometric method proved to be simple, accurate, precise, and robust for the estimation of
lobeglitazone in bulk and its formulation with application of Quality by Design.
Keywords: Lobeglitazone, UV spectroscopy, QbD, Method Validation, Design Expert 12.0.
Publication date: 01/08/2025
https://ijbpas.com/pdf/2025/August/MS_IJBPAS_2025_9371.pdf
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https://doi.org/10.31032/IJBPAS/2025/14.8.9371
