Implementation of QbD Principles for Simultaneous Quantitative Expression of Olmesartan Medoxomil, Telmisartan and Hydrochlorothiazide by RP-HPLC

Abstract

Aim and Study Design: Aims: The current research paper describes the RP-HPLC Method for estimation of Olmesartan Medoxomil, Telmisartan, and Hydrochlorothiazide and implements the role of QbD for Data Analysis Study design: Mentioned study is simple, rapid, economical, accurate, and robust RP-HPLC Method for Olmesartan Medoxomil, Telmisartan, and Hydrochlorothiazide and implementing QbD Approach for Data Analysis. Place and Duration of Study: The present study was carried out at Smt. S. M. Shah Pharmacy College, Mahemdabad, Gujarat, India from October 2019 to February 2020. Methodology: The separation was done on Hypersil ODS C18 column with dimensions (250mm x 4.6ID, Particle size: 5 microns) and Methanol: 0.02M potassium dihydrogen phosphate buffer (60:40%v/v) pH 3 used as mobile phase. The flow rate was 1.2ml/min; detection at 254nm. QbD approach was applied for data analysis. The method was validated according to ICH guidelines. Results: The RP-HPLC method was developed and validated for Linearity and Range through the QbD approach. Factorial Design was developed through Design Expert Software for estimation of Telmisartan, Olmesartan Medoxomil, and Hydrochlorothiazide. 27 experiments were constructed and its effect was seen on Resolution, Tailing factor, and Retention Time. Conclusion: It was clear that the proposed method was suitable for the QbD approach and identification and validation approaches. This process helps in the proper understanding of the parameters and less amount of time for the development cycle of the analytical method.