Articles Accepted

SIMULTANEOUS QUANTIFICATION OF ACTIVE PHARMACEUTICAL INGREDIENT BY UV AND QUALITY BY DESIGN ASSISTED HPLC METHOD
by Dr. Balak Das Kurmi, 18 Jun 2021
Co-Author(s): Geeta Rajput,Saranjit Singh

Objective: Nowadays, most pharmaceutical formulations contain more than one drug because there are numerous advantages of multi-component formulations like patient compliance, enhance efficacy, synergetic effects of both drugs, etc. This review paper describes the simultaneous estimation methods such as UV spectroscopy and high HPLC for the determination of various drug molecules and/or active pharmaceutical ingredients (API). In addition, the implementation of the quality by design (Qbd) principle is used to illustrate how these approaches can be developed and validated. Method: The estimation of the drug content in these multi-component formulations, several ultraviolet (UV) spectroscopy and high performance liquid chromatography (HPLC) methods have been developed and validated as per available literature. UV spectrophotometry and HPLC are among the most critical tools in the analysis of the drugs in pharmaceutical formulations. As per ICH Q8(R2) guideline by the applying the Qbd approach in the development of the simultaneous could be designed with predefined objectives that emphasize product and process to maintain the quality desired. Results: This review article gives brief information regarding the various Qbd optimized UV and HPLC methods for simultaneous estimation of multi-component formulations and their recent applications and elaborates multiple steps in method development in the HPLC method along with their applications. Conclusion: The available information was very informative towards the multi-component analysis and will open new paradigms in the upcoming research in the field of analysis.

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