Degradation studies on lurasidone hydrochloride using validated reverse phase HPLC and LC-MS/MS.

IF 1.3 4区医学 Q4 PHARMACOLOGY & PHARMACY

Xenobiotica Pub Date : 2025-03-01 Epub Date: 2025-05-12 DOI:10.1080/00498254.2025.2498699

Tanvi Kadam, Surendra Agarwal, Saritha Shetty

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引用次数: 0

Abstract

The research aims to develop and validate a stability-indicating reverse phase high-performance liquid chromatography (RP-HPLC) method for Lurasidone hydrochloride, an antipsychotic drug derived from benzisothiazole derivatives.A Binary Gradient HPLC System with a PDA detector, C18 column (4.6 x 100 mm, 2.5 mm), and a Shimadzu 8040 series triple quadrupole mass analyzer with an electron spray ionizer was used for the LC-MS/MS analysis.The method was linear in the concentration range of 10-50 μg/mL with a correlation coefficient (r²) of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were 0.091 μg/mL and 0.275 μg/mL, respectively. Validation included accuracy, percentage recovery, robustness, system suitability, and interday and intraday precision. Forced degradation studies were conducted in acid, alkali, oxidative, neutral, and photolytic conditions after 1, 2, and 6 hours, and in oxidative conditions for 24 hours. Degraded products were evaluated on LC-MS (100 m/z to 550 m/z). Lurasidone was more susceptible to alkali hydrolysis, with fragmentation peaks at 109, 166, 220, and 317 m/z. and possible fragmentation pattern was also evaluated.This method is used for routine quality control analysis as a stability-indicating method of Lurasidone hydrochloride in pharmaceuticals, and the LC-MS data is used for evaluating stability and identifying drug intermediates.

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反相高效液相色谱法和LC-MS/MS法研究盐酸鲁拉西酮的降解。

1. 本研究旨在建立并验证一种稳定性指示的反相高效液相色谱（RP-HPLC）方法对盐酸鲁拉西酮（一种由苯并异噻唑衍生物衍生的抗精神病药物）进行分析。采用双梯度高效液相色谱系统，采用PDA检测器，C18色谱柱（4.6 × 100 mm, 2.5 mm），岛津8040系列三重四极杆质谱分析仪，带电子喷雾电离器。该方法在10 ~ 50 μg/mL浓度范围内线性良好，相关系数（r2）为0.999。检出限为0.091 μg/mL，定量限为0.275 μg/mL。验证包括准确性、百分比回收率、鲁棒性、系统适用性以及日内和日内精度。在酸、碱、氧化、中性和光解条件下进行1、2和6小时的强制降解研究，在氧化条件下进行24小时。降解产物在LC-MS （100 m/z ~ 550 m/z）上进行评价。鲁拉西酮更易被碱水解，其破碎峰分别为109、166、220和317 m/z。并对可能的破碎格局进行了评价。该方法可作为药物中盐酸鲁拉西酮的稳定性指示方法，用于常规质量控制分析，LC-MS数据可用于稳定性评价和药物中间体鉴定。

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来源期刊

Xenobiotica 医学-毒理学

CiteScore

3.80

自引率

5.60%

发文量

审稿时长

2 months

期刊介绍： Xenobiotica covers seven main areas, including:General Xenobiochemistry, including in vitro studies concerned with the metabolism, disposition and excretion of drugs, and other xenobiotics, as well as the structure, function and regulation of associated enzymesClinical Pharmacokinetics and Metabolism, covering the pharmacokinetics and absorption, distribution, metabolism and excretion of drugs and other xenobiotics in manAnimal Pharmacokinetics and Metabolism, covering the pharmacokinetics, and absorption, distribution, metabolism and excretion of drugs and other xenobiotics in animalsPharmacogenetics, defined as the identification and functional characterisation of polymorphic genes that encode xenobiotic metabolising enzymes and transporters that may result in altered enzymatic, cellular and clinical responses to xenobioticsMolecular Toxicology, concerning the mechanisms of toxicity and the study of toxicology of xenobiotics at the molecular levelXenobiotic Transporters, concerned with all aspects of the carrier proteins involved in the movement of xenobiotics into and out of cells, and their impact on pharmacokinetic behaviour in animals and manTopics in Xenobiochemistry, in the form of reviews and commentaries are primarily intended to be a critical analysis of the issue, wherein the author offers opinions on the relevance of data or of a particular experimental approach or methodology