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Volume 20, Issue 5
  • ISSN: 1573-4129
  • E-ISSN: 1875-676X

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 60F, 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.

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/content/journals/cpa/10.2174/0115734129303749240607083542
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Synchronized Assessment of Lobeglitazone Sulfate and Metformin Hydrochloride in Tablet by Robust, High-performance Thin-layer Chromatographic Method
Current Pharmaceutical Analysis 20, 345 (2024); https://doi.org/10.2174/0115734129303749240607083542
/content/journals/cpa/10.2174/0115734129303749240607083542
/content/journals/cpa/10.2174/0115734129303749240607083542
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  • Article Type:     Research Article
Keyword(s): aluminum plates; Antidiabetic agent; high-performance thin-layer chromatography; lobeglitazone sulfate; metformin hydrochloride; tablet formulation

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