Abstract
Objective: Nowadays, most pharmaceutical formulations contain more than one drug because there are numerous advantages to multicomponent formulations, like patient compliance, enhanced efficacy, synergetic effects of both drugs, etc. This review paper describes the simultaneous estimation methods such as UV spectroscopy and high-performance liquid chromatography (HPLC) to determine various drug molecules and active pharmaceutical ingredients (APIs). In addition, the implementation of the quality by design (QbD) principle is used to illustrate how these approaches can be developed and validated.
Methods: To estimate the drug content in these multicomponent formulations, several UV spectroscopy and HPLC methods have been developed and validated as per the available literature. UV spectrophotometry and HPLC are among the most critical tools in the analysis of drugs in pharmaceutical formulations. The QbD based optimization approach applies to developing the simultaneous estimation method, which could be designed with predefined objectives, that emphasize the product and process to maintain the desired quality. The QbD approach followed the guidelines mentioned in ICH Q8 (R2).
Results: This review article gives brief information regarding the various QbD optimized UV and HPLC methods for simultaneous estimation of multicomponent formulations and their recent applications and elaborates on multiple steps in the development of the HPLC method along with their applications.
Conclusion: The available information is very informative for multicomponent analysis, and it will open new paradigms in upcoming research in the field of analysis.
Keywords: Quality by Design, Method development, UV, HPLC, Multi-component analysis, Simultaneous estimation.
Graphical Abstract
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