A Stability Indicating UHPLC Method for the Simultaneous Estimation of Perindopril, Indapamide in Presence of Potential Impurities: An Application of QbD for Robustness Study

Mohan, T.S.S. Jagan; Jogia, Hitesh; Mukkanti, K.

doi:10.1080/22297928.2020.1817776

Cited by 5 publications

(1 citation statement)

References 8 publications

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“…There are also some scholars who introduce quality-by-design principles when they establish analysis methods to obtain the best analysis method, so as to save analysis time and mobile phase consumption. 40…”

Section: Reversed Phase-high Performance Liquid Chromatographymentioning

confidence: 99%

Research progress on the impurities identification and determination in pharmaceuticals

Chen

Zhang

et al. 2023

Preprint

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Rationale: Impurities refer to any substances that affect the purity of pharmaceuticals. Controlling impurities has always been a significant concern during drug development. Impurities impact the drug’s purity, diminish the efficacy of pharmaceuticals, and alter their appearance, physical, and chemical properties. Additionally, impurities can compromise the stability of pharmaceuticals and elevate their toxic and side effects. Methods: Impurity source analysis is the basis of drug impurity control. To clarify the source of impurity can optimize the synthesis process, prescription process, packaging and storage conditions of the pharmaceuticals, and control the impurity within a reasonable limit to achieve the ultimate goal of impurity research. Results: Analysis method is a means to obtain impurity information, and diversified analysis methods are also possible for effective control of different types of impurities. At present, there are relatively many quantitative studies on impurities, but there are still some challenges for the structure analysis of impurities, especially trace impurities. Conclusion: The research progress of drug impurity control and evaluation from the sources of various drug impurities and impurity analysis techniques was reviewed in this article, with the aim of providing references for the related research.

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Section: Reversed Phase-high Performance Liquid Chromatographymentioning

confidence: 99%