通过RP-HPLC对达帕格利弗洛辛的分析方法开发,验证和强制降解研究
Ujwal Chaudhari1, Jagdish K Sahu1, Payal R Dande1
1School of Pharmacy & Technology Management, SVKM's NMIMS (Deemed to be University), Shirpur, Distt - Dhule (Maharashtra), 425405, India.
Drug metabolism and bioanalysis letters
|August 24, 2023
概括
一种新的稳定性指示HPLC方法可以准确地检测API中的达帕格利弗洛辛. 这种经过验证的方法在各种压力条件下证明了药物的稳定性,确保了药品质量控制的可靠分析.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
背景情况:
- 2型糖尿病 (T2DM) 影响全球数百万人,目前的治疗方法有局限性.
- 需要创新的疗法来有效管理T2DM.
研究的目的:
- 开发和验证一个稳定性指示的高性能液态染色学 (HPLC) 方法,用于达帕格利弗洛辛.
- 使用开发的方法评估达帕格利弗洛辛的特异性和稳定性.
主要方法:
- 开发了一种稳定性指示逆相HPLC (RP-HPLC) 方法,使用Kromasil C18列和紫外线检测.
- 方法验证遵循国际协调理事会 (ICH) 的指导方针.
- 压力降解研究在酸性,性,氧化,热性和光解条件下进行.
主要成果:
- 通过HPLC方法实现了1.67分钟的保留时间,所有系统适用性参数都在可接受的范围内.
- 达帕格利弗洛辛在光解,热,中性,性和氧化应激下表现出稳定性.
- 该方法的验证参数 (线性,精度,稳定性) 符合ICH Q2标准.
结论:
- 开发的HPLC方法具有稳定性指标,并且针对达帕格利弗洛辛特异性.
- 这种经过验证的方法可以可靠地用于分析平板药剂形式的达帕格利弗洛辛.
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