现代色谱法评价氯雷他定及其对保健的影响

IF 1.2 Q4 HEALTH POLICY & SERVICES

International Journal of Human Rights in Healthcare Pub Date : 2021-10-11 DOI:10.1108/ijhrh-08-2021-0154

H. AL-Salman, Q. A. Qasim, R. H. Fayadh, H. Hussein

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引用次数: 0

摘要

目的采用高效液相色谱技术，建立氯雷他定纯化制剂和胶囊制剂中氯雷他定的定量方法。根据国际协调会议[ICH]的原则对该方法进行了评估。Arcus EP-C18 Ion Pac色谱柱，5米，4.6 mm, 250 mm，流动相甲醇:乙腈(60:40)v/v。磷酸二钾缓冲液，pH 7.2，流速1.0 ml/min。设计/方法学/方法HPLC系统采用340 nm紫外检测器进行检测。10分钟的运行时间用于分析。在浓度为2 ~ 10 g/ml范围内，该方法具有良好的线性(R2 = 0.9998)、精确(日内和日间相对标准偏差[RSD]值为1.0%)、准确(范围回收率为96% ~ 102%)、专属性和强稳定性。结果检测限为0.92 g/ml，定量限为2.15 g/ml。原创性/价值研究结果表明，该方法可以快速准确地确定散装和丸剂剂型的LRD。

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Modern chromatographic method for estimating Loratadine and affections on healthcare

Purpose The purpose of this study is to establish Loratadine [LRD] quantification in purified and capsule formulations using a precise and specific Reversal Phase with a very high-performance liquid Chromatographic [RP-HPLC] technique. The approach was evaluated in agreement with the principles of the International Conference on Harmonization [ICH]. Arcus EP-C18 Ion Pac column, 5 m, 4.6 mm, 250 mm, mobile phase Methanol: Acetonitrile (60:40) v/v. Dibasic potassium phosphate buffer, pH 7.2, flow rate 1.0 ml/min. Design/methodology/approach The HPLC system used a 340 nm UV detector for testing. A 10-min run time was used for the analysis. At concentrations ranging from 2 to 10 g/ml, the technique was linear (R2 = 0.9998), exact (intra-day and inter-day relative standard deviation [RSD] values 1.0%), accurate (range recovery = 96%–102%), exclusive and strong. Findings The detecting and quantitation limits were 0.92 g/ml and 2.15 g/ml, respectively. Originality/value The findings demonstrated that the proposed method could accurately determine LRD in bulk and pill dose formats quickly and accurately.

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来源期刊

International Journal of Human Rights in Healthcare HEALTH POLICY & SERVICES-

CiteScore

2.90

自引率

7.10%

发文量

期刊介绍： nternational Journal of Human Rights in Healthcare (IJHRH) is an international, peer reviewed journal with a unique practical approach to promoting race equality, inclusion and human rights in health and social care. The journal publishes scholarly and double blind peer-reviewed papers of the highest standard, including case studies and book reviews. IJHRH aims include: -To explore what is currently known about discrimination and disadvantage with a particular focus on health and social care -Push the barriers of the human rights discourse by identifying new avenues for healthcare practice and policy internationally -Create bridges between policymakers, practitioners and researchers -Identify and understand the social determinants of health equity and practical interventions to overcome barriers at national and international levels. The journal welcomes papers which use varied approaches, including discussion of theory, comparative studies, systematic evaluation of interventions, analysis of qualitative data and study of health and social care institutions and the political process. Papers published in IJHRH: -Clearly demonstrate the implications of the research -Provide evidence-rich information -Provoke reflection and support critical analysis of both challenges and strengths -Share examples of best practice and ‘what works’, including user perspectives IJHRH is a hugely valuable source of information for researchers, academics, students, practitioners, managers, policy-makers, commissioning bodies, social workers, psychologists, nurses, voluntary sector workers, service users and carers internationally.