Quality by Design (QbD): A Practical Experimental Design Approach by Blocking and Varying Certain Factors of a Stability-Indicating HPLC Method for Simultaneous Determination of Omeprazole and Ketoprofen

Autor:	T. Krishnamurthy, Lovleen Kumar Garg, Shakil S. Sait, C. H. R. Phani Kumar
Rok vydání:	2014
Předmět:	Ketoprofen Flowchart Chromatography Chemistry Design of experiments Clinical Biochemistry Pharmaceutical Science Factorial experiment Biochemistry Quality by Design Analytical Chemistry law.invention Robustness (computer science) law Stability indicating medicine Hplc method medicine.drug
Zdroj:	Journal of Liquid Chromatography & Related Technologies. 38:677-686
ISSN:	1520-572X 1082-6076
DOI:	10.1080/10826076.2014.951766
Popis:	This manuscript demonstrates a Quality by Design approach using Design of Experiments to prove the robustness of a stability indicating HPLC method. The method determines the omeprazole in the presence of eight related substances and ketoprofen with six impurities developed for pellets filled capsule as a combined finished drug product. Based on the results, controllable factors that have influential effect on the resolution between peaks were identified and were examined while blocking the uncontrollable factors. The design employs a full factorial design of experiment for the interaction of controllable factors. A flowchart parades all steps of QbD approach by blocking and varying certain factors. Thus, the primary objective of this manuscript is to demonstrate the method's robustness by clarifying various steps systematically.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::419695a54c75e650cbea7effa14d54fb https://doi.org/10.1080/10826076.2014.951766 Zobrazit plný text záznamu