Analytical quality by design-based stability-indicating high performance liquid chromatography method for the estimation of evogliptin tartrate in bulk and tablet dosage form

IF 1.8 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS Biomedical Chromatography Pub Date : 2024-09-03 DOI:10.1002/bmc.5994

Shruti Srivastava, Suneela Dhaneshwar, Neha Kawathekar

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Abstract

The present study utilized Analytical Quality by Design (AQbD) approach to develop a stability-indicating high-performance liquid chromatography (HPLC) method for estimating evogliptin tartrate using design expert software. The key parameters were methodically optimized, contours were plotted, and stability was evaluated using various forced degradation conditions. Using an Agilent HPLC system with a photo diode array (PDA) detector along with Fortis C18 column (250 × 4.6 mm, 5 μm) effectively separated the drug from its degradants. The mobile phase used was methanol: water (pH adjusted to 3.0, 76:24; v/v) at 0.8 mL/min flow rate. Evogliptin was eluted at 2.98 min, at a detection wavelength of 267 nm. The proposed method was found to be specific, precise, linear and robust. The drug was sensitive to acidic, basic, oxidative, thermal, and photodegradation resolving six degradation products. Thus, the developed AQbD-based stability-indicating HPLC method is applicable in analyzing evogliptin in bulk, tablet dosage form and stability samples.

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基于设计的稳定性指示高效液相色谱法估算酒石酸依维列汀散剂和片剂的分析质量。

本研究采用设计质量分析法（AQbD），利用设计专家软件开发了一种估算酒石酸依维列汀稳定性的高效液相色谱法（HPLC）。该方法对关键参数进行了优化，绘制了等值线，并利用各种强制降解条件对稳定性进行了评估。安捷伦高效液相色谱仪配有光电二极管阵列（PDA）检测器和 Fortis C18 色谱柱（250 × 4.6 mm，5 μm），可有效分离药物及其降解物。流动相为甲醇：水（pH 值调至 3.0，76:24；v/v），流速为 0.8 mL/min。依维列汀的洗脱时间为 2.98 分钟，检测波长为 267 nm。该方法特异、准确、线性、稳健。该药物对酸性、碱性、氧化性、热降解和光降解敏感，可分离出六种降解产物。因此，所开发的基于AQbD的稳定性指示高效液相色谱法适用于分析散装、片剂和稳定性样品中的依维列汀。

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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.