开发并验证了用于同时分析某些心血管药物的RP-HPLC方法

Q3 Pharmacology, Toxicology and Pharmaceutics
V. Pawar, H. More
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引用次数: 0

摘要

目的:建立并验证了一种符合ICH的RP-HPLC方法,以测量散装和混合药物剂型中HCTZ和LIS的浓度。该程序随后提交认证。方法:采用Phenomenex Luna C18(2)(250 x 4.6 mm,5μ)柱,甲醇:甲酸(30:70)流动相,流速为01 mL/min,检测波长为215 nm,所用检测器为PDA。结果:氢氯噻嗪(HCTZ)和赖诺普利(LIS)在4.0~6.0和10.0~15.0μg/mL浓度范围内均具有线性校准曲线(r2分别为0.9973和0.9983)。所提出的技术在3.97分钟内洗脱LIS,在4.53分钟内洗脱氢氯噻嗪。赖诺普利的回收率为99.31至99.83%,氢氯噻嗪的回收率则为100.75至101.16%。在分别为1.22和0.31μg/mL时,HCTZ和LIS的检测值最低。研究发现,赖诺普利和氢氯噻嗪的LoQ分别为0.97和3.75μg/mL。结论:现有的RP-HPLC技术可靠、简便、准确、线性、高效、快速。由于分析周期较短,该方法在两种化合物之间提供了更好的分辨率。因此,有足够的证据将该方法纳入各种制药公司和学术机构的赖诺普利和氢氯噻嗪定期分析中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Developed and Validated RP-HPLC Method for Concurrent Analysis of Some Cardiovascular Drugs
Objective: An ICH-compliant RP-HPLC approach was created and validated in order to measure the concentrations of HCTZ and LIS in bulk and mixed medicinal dosage forms. This procedure was subsequently submitted for certification. Methods: Column, a Phenomenex Luna C18(2) (250 x 4.6 mm, 5μ) with a Methanol: Formic acid (30:70) mobile phase, a flow rate is kept as 01 mL/min, the wavelength of detection was 215 nm, and a used detector was PDA. Results: Hydrochlorothiazide (HCTZ)) and lisinopril (LIS) both had linear calibration curves (r2 = 0.9973 and 0.9983, respectively) for the ranges of concentration 4.0 to 6.0 and 10.0 to 15.0 μg/mL. The proposed technique eluted LIS in 3.97 minutes and hydrochlorothiazide in 4.53 minutes. Lisinopril had a recovery rate of 99.31 to 99.83%, whereas hydrochlorothiazide had a recovery rate of 100.75 to 101.16%. At 1.22 and 0.31 μg/mL, respectively, HCTZ as well as LIS had the lowest detectable values. It was found that the LoQs for lisinopril and hydrochlorothiazide were 0.97 and 3.75 μg/mL, respectively. Conclusion: It was found that the current RP-HPLC technique is reliable, simple to use, accurate, linear, efficient, and rapid. With a shorter analysis period, this method offers better resolution between the two compounds. Therefore, there is sufficient evidence to include the approach in regular lisinopril and hydrochlorothiazide analysis in a variety of pharmaceutical companies and academic institutions.
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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%
发文量
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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