稳定性指示紫外分光光度法测定滴眼液中氟比洛芬的含量

IF 0.4 4区 医学 Q4 PHARMACOLOGY & PHARMACY Indian Journal of Pharmaceutical Sciences Pub Date : 2023-01-01 DOI:10.36468/pharmaceutical-sciences.1141
C. Ponnam, G. N. Challa, S. R. Yarraguntla
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引用次数: 0

摘要

建立了一种高效、快速、灵敏、可靠的氟比洛芬滴眼液稳定性指示紫外分光光度法。以甲醇为溶剂,检测波长为248 nm。验证参数的线性、检出限和定量限、准确性、精密度和特异性均根据国际协调理事会指南进行实验。考察了氟比洛芬在酸性、碱性、热和光解条件下的稳定性。在2 ~ 10 ug/ml浓度范围内,动力学呈线性关系,相关系数为0.992。日内和日间准确度的相对标准偏差百分比小于2%,从研究中检索到的药物为99.6% - 100.4%。该系统能够识别与应力条件有关的变化,尽管降解产物的应力条件尚未确定。该方法可作为常规滴眼液药物分析中氟比洛芬筛选的稳定性指示方法,具有显著的线性、准确度和精密度。结果表明,该方法既经济实惠,又方便。因此,该方法可用于在没有精密设备的小型工业中研究氟比洛芬的应力降解行为。
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Quantification of Flurbiprofen in Eye Drops by Stability Indicating Ultraviolet Spectrophotometric Method
Ponnam et al. : Stability Indicating Ultraviolet Spectrophotometric Method for Flurbiprofen An efficient, rapid, sensitive, validated stability-indicating ultraviolet spectrophotometric method was developed for flurbiprofen in eye drops. Methanol was employed as the solvent in this proposed process, and detection was carried out at a wavelength of 248 nm. The validation parameters linearity, limit of detection and limit of quantitation, accuracy, precision and specificity were all the subject of experiments according to International Council on Harmonisation guidelines. The stability of flurbiprofen was examined under acidic, alkaline, thermal, and photolytic conditions. The kinetics in the concentration range of 2-10 ug/ml were defined as linear with a correlation value of 0.992. The percentage of relative standard deviation for both intra-day and inter-day accuracy was under less than 2 % and 99.6 %-100.4 % of the drug was retrieved from the study. The system was able to identify variations related to stress conditions although the stress condition of degradation products hadn't been determined. The proposed approach can be employed as a stability indicating method for flurbiprofen screening in conventional pharmaceutical analysis of eye drops with a significant level of linearity, accuracy and precision. The method was found to be both affordable and convenient. This method can therefore be used to study flurbiprofen stress degradation behaviour in small industries without access to sophisticated equipment.
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期刊介绍: The Indian Journal of Pharmaceutical Sciences (IJPS) is a bi-monthly Journal, which publishes original research work that contributes significantly to further the scientific knowledge in Pharmaceutical Sciences (Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy and Phytochemistry, Pharmacology and Therapeutics, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Pharmacovigilance, Pharmacoepidemiology, Pharmacoeconomics, Drug Information, Patient Counselling, Adverse Drug Reactions Monitoring, Medication Errors, Medication Optimization, Medication Therapy Management, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest). The Journal publishes original research work either as a Full Research Paper or as a Short Communication. Review Articles on current topics in Pharmaceutical Sciences are also considered for publication by the Journal.
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