用逆相高性能液态染色法对药物剂量形式中的塞夫特里亚的定性和定量估计
Hibba Dar1, Rehana Tabassum1, Younis Rather2
1Department of Pharmacology, Government Medical College, Srinagar, Jammu and Kashmir, India.
JMA journal
|February 12, 2026
概括
这项研究开发了一种敏感的HPLC方法,用于测试印度的塞夫triaxone质量. 虽然大多数品牌都符合标准,但10.5%的品牌不符合标准,这凸显了制药供应链中的关键质量差异.
科学领域:
- 药品分析 药品分析
- 分析化学 分析化学
背景情况:
- 印度是全球主要的制药供应商.
- 对来自印度的劣质和伪造药物存在担忧.
- 查和克什米尔地区先前发生的 ceftriaxone 的质量问题需要进一步调查.
研究的目的:
- 开发和验证一种基于高性能液体染色学 (HPLC) 的精细分析方法,用于验证 ceftriaxone 的质量.
- 评估在查和克什米尔可供注射的塞夫特里亚克森配方的质量.
主要方法:
- 使用具有紫外线检测的Agilent 1260 Infinity系统开发了一种逆相HPLC方法.
- 该方法根据国际协调理事会 (ICH) 的指导方针进行了验证.
- 分析了19个注射式塞夫特里亚克森品牌的药典标准合规性.
主要成果:
- 经过验证的HPLC方法显示出出色的线性 (R2 = 0.9991),灵敏度 (LOD:5.88 μg/mL,LOQ:17.83 μg/mL) 和稳定性.
- 实现了高精度 (96.9%-102.6%的恢复) 和精度 (%RSD <2%).
- 在19种配方中,89.5%符合药典标准,但10.5% (两个品牌) 低于标准.
结论:
- 一种简单,灵敏和具有成本效益的HPLC方法已成功开发和验证,用于对 ceftriaxone 的估计.
- 该研究发现了塞夫特里亚克森产品质量的显著变化,其中显著的比例是低于标准的配方.
- 确保药品质量的一致性对于全球健康和印度作为药物供应商的作用至关重要.
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