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稳定性指示HPLC用于雷莫格利弗洛辛,维尔达格利普丁和美特福林:方法开发,验证和绿色化

Himani Acharya¹, Rajendra Kotadiya¹

¹Department of Pharmaceutical Quality assurance, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), CHARUSAT Campus, Changa, Anand, 388421 Gujarat, India.

Annales pharmaceutiques francaises

|June 30, 2024

概括

一种新的HPLC方法准确地量化了雷莫格利弗洛辛乙酸盐,维尔达格利普丁和甲胺HCl在片中的含量. 这种经过验证的技术对于稳定性测试和常规质量控制是有效的.

科学领域:

分析化学分析化学
药品分析药品分析

背景情况:

在复杂配方中同时估计多种活性药物成分 (API) 会带来分析挑战.
稳定性研究对于确保药品质量和保质期至关重要.

研究的目的:

开发和验证一个逆相高性能液体染色学 (RP-HPLC) 方法,用于测定雷莫格利弗洛辛乙酸乙酸盐,维尔达格利普丁和甲胺HCl的序列估计.
在各种压力条件下评估这三种药物的稳定性.

主要方法:

使用了Phenomenex Luna C18柱,其中有一个移动阶段的酸盐缓冲剂 (pH 6.8) 和酸 (50:50 v/v).
使用0.8毫升/分钟的流量,运行时间为20分钟,注射量为20微升,使用PDA探测器在217纳米处检测.
根据ICH Q2 (R1) 准则验证了该方法,并将药物组合置于酸,,热,光解和氧化应激条件下.

主要成果:

开发的RP-HPLC方法表现出良好的线性,准确性,精度和灵敏度.
这种组合在氧化,酸性和基本应激条件下显著降解.
该方法成功识别和量化了降解产品,证实了其稳定性指示能力.

结论:

开发的方法是快速,精确,灵敏和准确的,用于同时估计雷莫格利弗洛辛乙酸,维尔达格利普丁和甲胺HCl.
这种经过验证的分析技术适用于制药行业的常规质量控制和稳定性监测.

关键词:

强度降解研究的研究.这种形式的药物被打包而成.在HPLC中使用HPLC.甲胺 HCl 的含量甲型胺 HCl 的含量雷莫格利弗洛辛和乙酸乙酸盐的使用平板电脑的剂量形式维尔达格利普丁 (Vildagliptin) 是一个非常重要的药物.维尔达格利普丁尼 (Vildagliptine) 是一个古镇.这是Remogliflozine的碳酸盐.强力降解研究.

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