A sensitive direct chiral liquid chromatography tandem mass spectrometry method for the enantio—Selective analysis of imeglimin in formulation

Q2 Pharmacology, Toxicology and Pharmaceutics

journal of applied pharmaceutical science Pub Date : 2023-01-01 DOI:10.7324/japs.2023.132349

Sangamithra Ramalingam, Meyyanathan Nainar Subramania, Babu Basuvan, R. Jaganathan, Anandha Jothi Dhavamani, N. K. Kandukuri, Ratnam Venkata Parimi, Sandeep Bodduna

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引用次数: 1

Abstract

The purpose of this study was to separate and develop a sensitive chiral liquid chromatography tandem mass spectrometry (LC-MS/MS) technique to estimate the (+) and (−) enantiomers of imeglimin in its formulation and validate individual enantiomer of the drug. Imeglimin is used to treat type-2 diabetes (T2D). The chiral stationary phase was reverse phase Chiralpak IG-3 (100 × 4.6 mm, 3 µm), whereas the isocratic mobile phase was methanol and 10 mM ammonium acetate (95:5 v / v ratio) and the flow rate was 0.5 ml/minutes. The resolution of the (+) and (−) enantiomers was monitored using LC-ESI-MS/MS in positive transition at 155.0 m / z (M+H) for imeglimin. The (+) and (−) linearity ranges from 10 to 100 ng/ml. The correlation co-efficient ( R 2 ) of the (+) and (−) imeglimin enantiomers was found to be linear. The retention time of the (+) and (−) enantiomers of the drug was 2.876 and 4.325 minutes and the total run time of the chromatographic resolution was 5 minutes. As a result, our goal is to separate the enantiomers and develop a fast, sensitive, and cost-effective method for estimating (+) and (−) enantiomers in its formulation.

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一种灵敏的直接手性液相色谱串联质谱法用于制剂中依米霉素的对映体选择性分析

本研究的目的是分离和建立一种灵敏的手性液相色谱-串联质谱(LC-MS/MS)技术，以估计伊美霉素制剂中的(+)和(−)对映体，并验证药物的单个对映体。依米霉素用于治疗2型糖尿病(T2D)。手性固定相为反相Chiralpak IG-3 (100 × 4.6 mm, 3µm)，等压流动相为甲醇- 10 mm乙酸铵(95:5 v / v比)，流速为0.5 ml/min。在155.0 m / z (m +H)正跃迁下，采用LC-ESI-MS/MS对伊米明(+)和(−)对映体进行分离。(+)和(−)线性范围为10至100 ng/ml。(+)和(−)对映体的相关系数r2为线性关系。药物的(+)和(−)对映体的保留时间分别为2.876和4.325分钟，色谱分辨率的总运行时间为5分钟。因此，我们的目标是分离对映体，并开发一种快速、敏感和经济有效的方法来估计其配方中的(+)和(−)对映体。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

journal of applied pharmaceutical science Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

2.20

自引率

0.00%

发文量

224

期刊介绍： Journal of Applied Pharmaceutical Science (JAPS) is a monthly, international, open access, journal dedicated to various disciplines of pharmaceutical and allied sciences. JAPS publishes manuscripts (Original research and review articles Mini-reviews, Short communication) on original work, either experimental or theoretical in the following areas; Pharmaceutics & Biopharmaceutics Novel & Targeted Drug Delivery Nanotechnology & Nanomedicine Pharmaceutical Chemistry Pharmacognosy & Ethnobotany Phytochemistry Pharmacology & Toxicology Pharmaceutical Biotechnology & Microbiology Pharmacy practice & Hospital Pharmacy Pharmacogenomics Pharmacovigilance Natural Product Research Drug Regulatory Affairs Case Study & Full clinical trials Biomaterials & Bioactive polymers Analytical Chemistry Physical Pharmacy.