设计驱动反相高效液相色谱法测定复方和双载制剂中肉桂利嗪和水合莫宁的条件。

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL
Abhinab Goswami, Syed Nazrin R Rahman, Datta M Pawde, Tamilvanan Shunmugaperumal
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引用次数: 0

摘要

背景:以樟脑和薄荷醇为基础的共晶混合物取代传统油,制备无油乳剂状分散体,用于联合递送肉桂嗪(CNZ)和水合桑胺(MH),以治疗menisamure病(MD)。由于两种药物被装载到分散体中,因此开发一种合适的反相高效液相色谱(RP-HPLC)方法来同时分析它们就成为必然。目的:采用设计质量法(AQbD),优化两种药物同时测定的反相高效液相色谱法条件。方法:系统AQbD首先通过石川鱼骨图、风险估计矩阵和基于风险优先级数的失效模式效应分析识别关键方法属性(CMA),然后采用分数析因设计进行筛选,再采用面心中心复合设计进行优化。通过联合药液的特异性检查、药物包封效率检查和两种药物在乳状分散体中的体外释放度检查,验证了优化后的反相高效液相色谱法条件下两种药物的同时测定。结果:AQbD优化的反相高效液相色谱法条件下,CNZ和MH的保留时间分别为5.017和5.323。所研究的验证参数均在ich规定的限度内。将单个药物溶液暴露于酸性和碱性水解条件下,可能是由于MH的降解,产生了额外的MH色谱峰。在乳状分散体中,CNZ和MH的DEE %分别为87.40±4.70和74.79±2.94。乳状分散体在人工淋巴周围溶出后30 min内释放出98%以上的CNZ和MH。结论:总体而言,AQbD方法有助于系统优化RP-HPLC方法条件,以估计伴随的其他治疗成分。重点:本文成功应用AQbD优化RP-HPLC法同时测定复方药物溶液和双载乳状分散体中CNZ和MH的条件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical Quality by Design-Driven RP-HPLC Method Conditions to Concomitantly Determine Cinnarizine and Morin Hydrate in Combined Drug Solution and Dual Drug-Loaded Formulations.

Background: The replacement of traditional oils with a camphor and menthol-based eutectic mixture is done to prepare oil-less emulsion-like dispersions for co-delivery of cinnarizine (CNZ) and morin hydrate (MH) for managing Meniére's disease (MD). Since two drugs are loaded into the dispersions, the development of a suitable reverse phase-high performance liquid chromatography (RP-HPLC) method for their simultaneous analysis becomes inevitable.

Objective: By applying the analytical quality by design (AQbD) approach, the RP-HPLC method conditions were optimized for the concomitant determination of two drugs.

Methods: The systematic AQbD started with identifying critical method attributes (CMA) through an Ishikawa fishbone diagram, risk estimation matrix, and risk priority number-based failure mode effect analysis followed by screening using fractional factorial design and optimization by face-centered central composite design. The concomitant determination of two drugs by the optimized RP-HPLC method condition was substantiated via specificity checking using combined drug solution, drug entrapment efficiency, and in vitro release of the two drugs from emulsion-like dispersions.

Results: The AQbD optimized RP-HPLC method conditions revealed the retention time for CNZ and MH at 5.017 and 5.323, respectively. The studied validation parameters were found within the ICH-prescribed limits. Exposing the individual drug solutions to acidic and basic hydrolytic conditions yielded extra chromatographic peaks for MH, probably due to the degradation of MH. The DEE % values of 87.40 ± 4.70 and 74.79 ± 2.94, respectively, were noticed for CNZ and MH in emulsion-like dispersions. More than 98% CNZ and MH release was occurred from emulsion-like dispersions within 30 min post-dissolution in artificial perilymph.

Conclusions: Overall, the AQbD approach could be helpful for systematic optimization of RP-HPLC method conditions to estimate concomitantly other therapeutic moieties.

Highlights: The proposed article shows the successful application of AQbD for the optimization of RP-HPLC method conditions to concomitantly estimate CNZ and MH in combined drug solution and dual-drug-loaded emulsion-like dispersions.

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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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