已验证的稳定性指示RP-HPLC方法用于达克拉塔斯维尔在片剂中.
Hemlata M Nimje1, Smita J Pawar1, Meenakshi N Deodhar2
1Pune District Education Association's Seth Govind Raghunath Sable College of Pharmacy, Department of Pharmaceutical Chemistry, Pune, India.
Turkish journal of pharmaceutical sciences
|August 22, 2023
概括
一种新的,经过验证的RP-HPLC方法精确测量达克拉塔斯维尔 (DCV) 和其稳定性. 该方法在酸性,基本性和氧化应激条件下成功识别了DCV降解剂,确保了药物的质量.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 达克拉塔斯维尔 (DCV) 是一种重要的直接作用抗病毒药物.
- 确保制药配方的稳定性和质量对于患者的安全性和治疗疗效至关重要.
研究的目的:
- 开发和验证一种精确而敏感的逆相高性能液态染色学 (RP-HPLC) 方法,用于达克拉塔斯维尔 (DCV) 分析.
- 通过评估在各种压力条件下DCV降解来评估开发的方法的稳定性指示能力.
主要方法:
- 在RP-HPLC分析中,使用C18列的Agilent 1100系统进行了分析.
- 使用了0.05%o-酸 (50:50v/v) 的移动相,流量为0.7mL/min,检测在315nm.
- 方法验证包括线性,准确性,精度,LOD,LOQ和根据ICH指南的稳定性.
主要成果:
- 经过验证的RP-HPLC方法在DCV分析方面表现出令人满意的性能.
- 在酸性,基本性和氧化应激条件下,DCV表现出降解,识别了降解剂及其保留时间.
- 在中性或光解条件下没有观察到显著的降解,这表明了方法的特异性.
结论:
- 开发的RP-HPLC方法是精确的,敏感的,并且对达克拉塔斯维尔的稳定性有指示.
- 该方法促进了DCV降解剂的识别,有助于了解降解途径并确保药物产品的质量.
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