开发和验证用于估计Tapinarof在局部配方和活性药物成分的估计
Raghunatha Reddy Chavva1, Nageswara Reddy Gosu2
1Sri Krishnadevaraya University, Department of Chemistry, Ananthapuramu, AP 515003, India.
Journal of AOAC International
|October 13, 2023
概括
一种新的反相高性能液态染色学 (RP-HPLC) 方法准确量化了局部配方和活性药物成分中的tapinarof. 这种验证的测定方法适用于常规质量控制分析.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 逆相高性能液态染色学 (RP-HPLC) 是一个公认的分析技术,因为它的多功能性.
- RP-HPLC在一次运行中分离多个组件方面表现出色.
研究的目的:
- 开发一种简单,准确和精确的方法来量化Tapinarof.
- 为了创建一个强大的HPLC测定,专门用于局部配方和活性药物成分的测试.
主要方法:
- 使用克罗莫西尔C18柱 (250 × 4.6毫米,5微米颗粒大小) 进行染色学分析.
- 用酸盐缓冲剂和甲醇 (100:900v/v) 的移动相以1.0mL/分钟的流量进行异离体化.
- 在313nm的紫外线检测,30°C的柱体温度,和10μL的注射体积.
主要成果:
- 一种优化的方法,90%的甲醇移动相和1.0毫升/分钟的流量.
- 塔皮纳罗夫表现出2.88分钟的保留时间,具有出色的峰值特性.
- 该方法在530微克/毫升度范围内证明了线性 (R2>0.999).
结论:
- 开发的方法是简单的,准确的,准确的量化 tapinarof.
- 光二极管阵列 (PDA) 检测证实了峰值完整性和纯度.
- 经过验证的方法被推用于常规质量控制 (QC) 分析.
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