Quantitative determination of lobeglitazone sulfate and glimepiride in combined tablet by robust high‐performance thin layer chromatographic method

IF 1.3 Q4 CHEMISTRY, ANALYTICAL

SEPARATION SCIENCE PLUS Pub Date : 2024-05-10 DOI:10.1002/sscp.202400059

A. Sen, Tantul Sarkar, D. Sen, R. Maheshwari, A. Zanwar, Rajesh L. Dumpala

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Abstract

A combination of fixed dose tablet containing 0.5 mg lobeglitazone sulfate (LBZ) and 1 mg glimepiride (GLM) has demonstrated efficacy in enhancing glycemic control in diabetes. The projected work aimed to develop and validate a high‐performance thin‐layer chromatographic (HPTLC) methodology for the precise quantification of both the drugs in tablet formulations. The HPTLC analysis utilized aluminium plates layered with silica gel 60F254, and the solvent system consisted of ethyl acetate, benzene, and hexane (4:3:1 v/v/v) followed by densitometric scanning at 238 nm. The Rf value was found to be 0.68 ± 0.001 for LBZ and 0.48 ± 0.002 for GLM. The methodology exhibited linearity in the range of 100–2000 ng/band for LBZ and 200–4000 ng/band for GLM, with correlation coefficients of 0.9988 and 0.9981, respectively. Exceptional sensitivity was observed, with detection limits of 23.86 ng/band for LBZ and 58.26 ng/band for GLM, along with quantification limits of 72.32 ng/band for LBZ and 176.55 ng/band for GLM. The method demonstrated precision (% relative standard deviation of peak area < 2) and accuracy (recovery between 97% and 102%). The suggested method is suitable for quantifying both the drugs in tablets, making it useful for routine quality control in laboratories.

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高效薄层色谱法定量测定复方片剂中的硫酸罗格列酮和格列美脲

含 0.5 毫克硫酸罗格列酮（LBZ）和 1 毫克格列美脲（GLM）的固定剂量片剂组合在加强糖尿病患者的血糖控制方面具有显著疗效。本项目旨在开发和验证一种高效薄层色谱（HPTLC）方法，用于精确定量片剂中的两种药物。HPTLC 分析采用硅胶 60F254 层叠铝板，溶剂系统包括乙酸乙酯、苯和正己烷（4:3:1 v/v/v），然后在 238 纳米波长下进行密度扫描。结果发现，LBZ 的 Rf 值为 0.68 ± 0.001，GLM 为 0.48 ± 0.002。该方法在 LBZ 和 GLM 的线性范围分别为 100-2000 纳克/带和 200-4000 纳克/带，相关系数分别为 0.9988 和 0.9981。灵敏度极高，LBZ 和 GLM 的检出限分别为 23.86 ng/带和 58.26 ng/带，定量限分别为 72.32 ng/带和 176.55 ng/带。该方法具有良好的精密度（峰面积相对标准偏差小于 2%）和准确度（回收率在 97% 至 102% 之间）。该方法适用于片剂中两种药物的定量分析，可用于实验室的常规质量控制。

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来源期刊

SEPARATION SCIENCE PLUS CHEMISTRY, ANALYTICAL-

CiteScore

1.90

自引率

9.10%

发文量

111

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