一种高效液相色谱法测定原料药和制剂中依托昔布的含量

Q3 Pharmacology, Toxicology and Pharmaceutics International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-06-25 DOI:10.25258/ijpqa.14.2.19
K. Patil, Swapnal Narkhede, Mahesh S Nemade, S. Rane, Rajesh Chaudhari, G. Dhobale, H. Tare
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引用次数: 1

摘要

目的:目前的研究旨在创建一种高分辨率、经验证的液相色谱方法,用于定量检测剂型中的依托里昔布,该方法在准确性、灵敏度和再现性方面既易于使用又可靠。材料和方法:在等度条件下,以0.7mL/min的流速进行分析,使用由40份甲醇与60份水(0.1%OPA)组成的流动相,pH 3.2。使用在236nm处的UV检测来测试洗脱液。结果:在优化的设置下,依托瑞昔具有清晰的分离峰,保留时间为4.347分钟。用于生成校准曲线的浓度范围为10至60μg/mL。LoD为0.0779μg/mL,上LoQ为0.23μg/mL。该方法在分离已知量的依托里昔布方面是有效的,并且在所有应力环境中降解的百分比都很低。结论:使用所提出的方法可以识别和定量原料药和商业制剂中的依他西,该方法已根据ICH建议进行了验证。
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A Validated Sensitive Stability Indicating HPLC Method for the Determination of Etoricoxib in Bulk and Formulation
Aim: The current research aims to create a high-resolution and validated liquid chromatographic method used for quantitative detection of etoricoxib within dosage forms that is both easy to use and reliable in terms of accuracy, sensitivity, and reproducibility. Materials and Methods: Analysis was carried out at isocratic conditions at flow rate of 0.7 mL/min using a mobile phase consisting of 40 parts methanol to 60 parts water (0.1% OPA) at pH 3.2. The eluents were tested using UV detection at 236 nm. Results: Etoricoxib had clearly separated peaks with a retention duration of 4.347 minutes in the optimized settings. The concentration range used to generate the calibration curve was 10 to 60 μg/mL. LoD was 0.0779 μg/mL, and upper LoQ was 0.23 μg/mL. The approach has been effective in separating a known quantity of etoricoxib, and the percentage of degradation was shown to be very low across all stress settings. Conclusion: Etoricoxib in bulk drug and commercial formulations can be identified and quantified using the proposed method, which has been validated in accordance with ICH recommendations.
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来源期刊
International Journal of Pharmaceutical Quality Assurance
International Journal of Pharmaceutical Quality Assurance Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
CiteScore
0.80
自引率
0.00%
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0
期刊介绍: INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE is a quarterly international journal publishing the finest peer-reviewed research in the field of Pharmaceutical Quality Assurance and Pharmaceutical Analysis on the basis of its originality, importance, disciplinary interest, timeliness, accessibility, elegance, and surprising conclusions. IJPQA also provides rapid, authoritative, insightful and arresting news and interpretation of topical and coming trends affecting science, scientists and the wider public.
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