通过设计计算质量策略来验证高性能液体染色学方法,用于估计大量剂量形式和牛奶样本中的梅洛西卡姆
Vaskuri G S Sainaga Jyothi1, Harithasree Veerabomma1, Chantibabu Katta1
1Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, India.
概括
一种新的RP-HPLC方法准确地量化了兽医学中的梅洛西卡姆. 这种经过验证的方法确保了药物的质量,并有助于比较梅洛西卡姆药片释放特征,以便更好地进行药物分析.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 兽医医学 兽医医学 兽医医学
背景情况:
- 牛临床乳腺炎对全球农业产生重大影响.
- 梅洛西卡姆是一种COX-2抑制剂,用于治疗牛的乳腺炎症状.
- 在兽药中精确量化活性药物成分 (API) 对于质量控制至关重要.
研究的目的:
- 开发和验证一种逆相高性能液体染色学 (RP-HPLC) 方法用于梅洛西卡姆分析.
- 使用设计质量 (QbD) 原则优化RP-HPLC方法.
- 评估兽用梅洛西卡姆药片和从牛奶样本中回收的梅洛西卡姆的体外生物等价性.
主要方法:
- 使用Box-Behnken设计 (BBD) 的RP-HPLC方法开发和优化.
- 方法验证根据ICH Q2 (R1) 准确性,线性,精度,范围,灵敏度和强度的指南进行验证.
- 在各种pH缓冲剂中溶解梅洛西卡姆片的试验室溶解研究和从牛奶样本中恢复梅洛西卡姆的分析.
主要成果:
- 优化的RP-HPLC条件:pH3水性移动相,65%ACN,30°C柱体温度,在6.02分钟 (RT) 产生梅洛西卡姆化,尾部系数为1.18.
- 经过验证的方法显示出高精度,线性,精度和稳定性.
- 试验室研究显示,两种梅洛西卡姆品牌之间的溶解效率和平均溶解时间有显著差异,释放特征相似,但pH值为6.8. 与甲醇相比,使用ACN提取方法从牛奶中恢复梅洛西卡姆的效果显著更高.
结论:
- 开发和验证的RP-HPLC方法适合量化药用剂型中的梅洛西卡姆.
- 该方法可用于在生物流体 (如牛奶) 中分析梅洛西卡姆.
- 在体外释放的比较研究提供了关于不同兽用梅洛西卡姆配方的性能的见解.
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