Title:Synchronized Assessment of Lobeglitazone Sulfate and Metformin Hydrochloride in Tablet by Robust, High-performance Thin-layer Chromatographic Method
Volume: 20
Issue: 5
Author(s): Dhanya B. Sen*, Krunal Baldha, Ashim K. Sen, Rajesh A. Maheshwari, Aarti S. Zanwar, Greeshma K. P. and Prasanna K. Pradhan
Affiliation:
- Department of Pharmacy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Vadodara-391760, Gujarat, India
Keywords:
Antidiabetic agent, high-performance thin-layer chromatography, lobeglitazone sulfate, metformin hydrochloride, tablet formulation, aluminum plates.
Abstract:
Background: A combination of fixed-doses containing 0.5 mg lobeglitazone sulfate
and 500 mg metformin hydrochloride has demonstrated efficacy in enhancing glycemic control in
diabetes.
Aims: The projected work aimed to establish and validate a high-performance thin-layer chromatographic
methodology for the quantification of both drugs in tablet formulations.
Objectives: The task involves creating and validating a method in accordance with ICH guidelines
to quantify two particular drugs in tablet formulations accurately.
Methods: The high-performance thin-layer chromatographic analysis utilized aluminum plates layered
with silica gel 60F254, and the solvent system consisted of acetonitrile, 1 M ammonium acetate
(methanol), toluene, and triethyl amine (1.5:2.5:4:0.2 v/v/v/v), followed by densitometric scanning
at 237 nm.
Results: The methodology exhibited linearity in the range of 100-1500 ng/band for lobeglitazone
sulfate and 1000-15000 ng/band for metformin hydrochloride, with correlation coefficients of
0.9991 and 0.9992, correspondingly. Exceptional sensitivity was observed, with detection limits
of 8.17 ng/band for lobeglitazone sulfate and 271.34 ng/band for metformin hydrochloride, along
with quantification limits of 24.75 ng/band for lobeglitazone sulfate and 822.24 ng/band for metformin
hydrochloride. The method demonstrated precision (% relative standard deviation of peak
area <2) and accuracy (recovery between 96 and 103%).
Conclusion: The suggested methodology is fit for the concurrent quantification of both drugs in
tablet formulations, making it applicable for routine quality control assessments in laboratories.
