Synchronized Assessment of Lobeglitazone Sulfate and Metformin Hydrochloride in Tablet by Robust, High-performance Thin-layer Chromatographic Method

Title:Synchronized Assessment of Lobeglitazone Sulfate and Metformin Hydrochloride in Tablet by Robust, High-performance Thin-layer Chromatographic Method

Volume: 20

Author(s): Dhanya B. Sen*, Krunal Baldha, Ashim Kumar Sen, Rajesh A. Maheshwari, Aarti S. Zanwar, K. P. Greeshma and Prasanna Kumar Pradhan

Affiliation:

• Department of Pharmacy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Vadodara-391760, Gujarat, India

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.

Aim: The projected work aimed to establish and validate a high-performance thin-layer chromatographic methodology for the quantification of both drugs in tablet formulations.

Objective: 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.

Cite this article as:

Sen B. Dhanya*, Baldha Krunal, Sen Kumar Ashim, Maheshwari A. Rajesh, Zanwar S. Aarti, Greeshma K. P. and Pradhan Kumar Prasanna, Synchronized Assessment of Lobeglitazone Sulfate and Metformin Hydrochloride in Tablet by Robust, High-performance Thin-layer Chromatographic Method, Current Pharmaceutical Analysis 2024; 20 () . https://dx.doi.org/10.2174/0115734129303749240607083542