Eco-Friendly Stability-Indicating HPLC Method for Related Compounds in Pemetrexed Ditromethamine (Antineoplastic Agent) for Injection

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL Journal of AOAC International Pub Date : 2024-02-04 DOI:10.1093/jaoacint/qsae008
Arjuna Rao Nekkalapudi, Srinivasu Navuluri, Sreenivas Pippalla
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Abstract

Background The Eco-friendly analytical technique was developed for intention of preserving the environment by using green chemistry principles. Pemetrexed is folate analogue indicated for treatment of advanced lung cancer. Objective Development of Green Stability indicating HPLC method for quantification of Pemetrexed (Ditromethamine) impurities in API and parenteral dosage form. Method Chromatographic separation was achieved by using Zorbax SB C18 column (150 mm x 4.6 mm inner diameter, 3.5 µ particle size) with perchlorate buffer (pH 3.0 ± 0.1, 50 mM) as a mobile phase-A and Acetonitrile—perchlorate buffer (90 + 10, v/v) as a mobile phase-B at a flow rate of 0.8 mL/minute with column temperature 40 °C ± 0.5 °C. All analytes were well resolved by gradient elution with total run time of 75 minutes and detection wavelength at UV 230 nm. Results The RP-HPLC method is capable to resolve all the degradation and process impurities for Pemetrexed Ditromethamine API and parenteral dosage form. The related compounds method was validated in accordance with ICH Q2(R1) and USP <1225> guidelines, found to be accurate, specific, precise, linear, robust and stability indicating. The precision and intermediate results shown the below < 5% CV values for all the impurities. The accuracy of all the impurities were found to be between 90% and 110%. The linearity of regression co-efficient values for all the impurities were found to be more than 0.999. Conclusion The proposed related compounds method is found suitable for the determination of process and degradation impurities of commercial formulations, stability samples in quality control analysis for Pemetrexed Ditromethamine (PDT) API and drug product. Highlights The developed liquid chromatographic method greenness and eco-friendliness were assessed by using (GAPI) green analytical procedure index, (AGREE) analytical greenness tool, and found to be green. Pemetrexed Ditromethamine detoxification procedure also developed to protect from environment pollution.
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注射用培美曲塞二甲胺(抗肿瘤药)中相关化合物的环保型稳定性指示 HPLC 方法
背景 环保型分析技术的开发旨在利用绿色化学原理保护环境。培美曲塞是叶酸类似物,用于治疗晚期肺癌。目标 开发绿色稳定的 HPLC 方法,用于定量检测原料药和肠外剂型中的培美曲塞(二甲胺基甲硝唑)杂质。方法 采用 Zorbax SB C18 色谱柱(内径 150 毫米 x 4.6 毫米,粒径 3.5 微米),以高氯酸盐缓冲液(pH 3.0 ± 0.1,50 毫摩尔)为流动相-A,乙腈-高氯酸盐缓冲液(90 + 10,v/v)为流动相-B,流速 0.8 毫升/分钟,柱温 40 °C ± 0.5 °C。通过梯度洗脱,所有分析物均得到很好的分离,总运行时间为 75 分钟,检测波长为紫外 230 纳米。结果 该 RP-HPLC 方法能够解析培美曲塞二甲胺原料药和肠外剂型的所有降解和加工杂质。根据 ICH Q2(R1) 和 USP <1225> 指南对相关化合物的方法进行了验证,结果表明该方法准确、特异、精确、线性、稳健且具有稳定性。所有杂质的精密度和中间值均低于 5%CV。所有杂质的准确度均在 90% 至 110% 之间。所有杂质的线性回归系数均大于 0.999。结论 所提出的相关化合物方法适用于测定商业制剂中的工艺杂质和降解杂质、培美曲塞二甲胺(PDT)原料药和药物产品质控分析中的稳定性样品。亮点 采用绿色分析程序指数(GAPI)和绿色分析工具(AGREE)对所开发的液相色谱法的绿色性和生态友好性进行了评估,结果表明该方法是绿色的。此外,还开发了培美曲塞二甲胺的解毒程序,以防止环境污染。
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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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