稳定性表明高性能薄层染色学方法的开发和验证,用于定量确定四环化在四环化活性药物成分 (API) 和其剂型中的四环化
Misganaw Gashaw1,2, Thomas Layloff3, Ariaya Hymete1
1Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box. 1176, Addis Ababa, Ethiopia.
BMC chemistry
|April 24, 2024
概括
开发了一种新的,具有成本效益的高性能薄层染色学 (HPTLC) 方法,用于分析四环素化物 (TC-HCl). 这种经过验证的方法可以与现有的药典技术互换,提供了强大的质量控制解决方案.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 需要简单,快速,具有成本效益和环保的分析方法,以确保像四环素这样的药物的质量.
- 现有的薄层染色学 (TLC) 方法缺乏现代高性能薄层染色学 (HPTLC) 方法.
研究的目的:
- 开发和验证一种新的HPTLC方法,用于四环素化物 (TC-HCl) 的质量控制.
- 为了比较开发的HPTLC方法与美国药典 (USP) 高性能液态染色法 (HPLC) 方法.
主要方法:
- 使用自动化HPTLC的方法开发和验证,使用凝60 F254板处理10%Na2EDTA.
- 根据国际协调理事会 (ICH) 的指导方针进行验证.
- 移动相组合:乙烯酸乙烯,乙二,甲醇和1%的水性氨 (4.4:19.6:10:6 V/V).
主要成果:
- 开发的HPTLC方法显示Rƒ值为0.28,百分比恢复率为100.83-106.25%,线性范围为160-560 ng/band (r2=0.9999),LOD为31.9 ng/band,LOQ为96.7 ng/band.
- 使用HPTLC (91.59%至108.3%) 的测试结果与USP HPLC (90.83%至102.85%) 的测试结果相当.
- 统计分析 (F测试) 证实了HPTLC和HPLC方法的可互换性.
结论:
- 新开发的HPTLC方法简单,经济,具体,准确和强大.
- 这种HPTLC方法可以有效地用于质量控制和保证 tetracycline 化在散装和膏剂的剂量形式.
- 该方法为TC-HCl分析的现有药典方法提供了可行的替代方案.
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