Bridging the Gap: Eco-Friendly HPLC Analysis of Metformin and Lobeglitazone Sulfate Despite Polarity and Dosage Differences

IF 1.7 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS Biomedical Chromatography Pub Date : 2025-02-11 DOI:10.1002/bmc.70013

Honey Kevat, Ayushi Prajapati, Kiran Parmar, Bhumika Maheriya, Hardi Joshi, Jigna Vadalia, Kashyap Thummar

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Abstract

A precise and stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the simultaneous estimation of lobeglitazone sulfate (0.5 mg) and metformin hydrochloride (500 mg) in pharmaceutical formulations. This method effectively addresses the analytical challenge posed by the significantly different dosage strengths and contrasting polarities of lobeglitazone (water insoluble) and metformin (water soluble). Utilizing a Phenomenex Strong Cation Exchange (250 mm × 4.6 mm, 10 μm) column, the method employed a mobile phase of ammonium dihydrogen phosphate (pH 3.0) and a premix of methanol and acetonitrile (80:20), delivered at a flow rate of 1.0 mL/min. The PDA detector was set at 251 nm to monitor eluents, and the column temperature was maintained at 30°C for optimal separation. The method was validated as per ICH guidelines, covering specificity, linearity, accuracy, precision, LOD, LOQ, solution stability, and robustness. Forced degradation studies under various stress conditions (acidic, basic, oxidative, photolytic, and thermal) revealed no significant degradation products. The method was also assessed for greenness using a AGREE tool, achieving a score of 0.68, demonstrating its eco-friendly nature. Overall, this method is suitable for the routine analysis of these drugs in pharmaceutical formulations.

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弥合差距：尽管极性和剂量不同，二甲双胍和硫酸洛贝列酮的生态友好型HPLC分析

建立了同时测定制剂中硫酸洛贝列酮（0.5 mg）和盐酸二甲双胍（500 mg）含量的高效液相色谱（HPLC）方法。该方法有效地解决了洛贝列酮（水不溶性）和二甲双胍（水溶性）的剂量强度和极性差异带来的分析挑战。该方法采用Phenomenex强阳离子交换柱（250 mm × 4.6 mm, 10 μm），流动相为磷酸二氢铵（pH 3.0），甲醇和乙腈（80:20）预混料，流速为1.0 mL/min。PDA检测器的波长为251 nm，柱温为30℃，以达到最佳分离效果。方法按照ICH指南进行验证，包括特异性、线性度、准确度、精密度、LOD、LOQ、溶液稳定性和鲁棒性。在各种胁迫条件下（酸性、碱性、氧化、光解和热）的强制降解研究表明，没有明显的降解产物。该方法还使用AGREE工具对绿色度进行了评估，得分为0.68，证明了其环保性。总之，该方法适用于制剂中这些药物的常规分析。

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来源期刊

Biomedical Chromatography 生物-分析化学

CiteScore

3.60

自引率

5.60%

发文量

268

审稿时长

2.3 months

期刊介绍： Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.