ABSTRACT

The pharmaceutical dosage forms of Hydrochlorothiazideand Olmesartan Medoxomil, a risk- assessed RP-HPLC technique was developed and validated in the current investigation using Quality by Design (QbD). The mobile phase, flow rate, and column temperature are crucial factors in the development of RP-HPLC procedures. Based on these variables, an effective experimental design was made with the help of Central Composite Design (CCD).It was discovered that Hydrochlorothiazide and Olmesartan Medoxomil had retention times of 2.47 and 3.66 minutes, respectively. The Design Expert software 13.0 version, Chemsil ODS column (C18 250 4.6 mm ID and 5?m particle size), Acetonitrile: Phosphate buffer (pH 3.2) in proportion of 70:30 v/v, and flow rate of 1.0 mL/min were used to optimise the chromatographic conditions. With a correlation coefficient (r2) of 0.9970 and 0.9987 for Hydrochlorothiazide and Olmesartan Medoxomil, respectively, at detection wavelength 261 nm, the linearity of the devised technique was validated over the concentration range of 10–50 ?g/mL and 5–25?g/mL. The created method is approved in accordance with ICH rules. Finally, using Design Expert 13.0, the CCD defines the interactions between mobile phase, flow rate, and column temperature at two different levels. Retention time, theoretical plates, and peak asymmetry were the responses to be seen. In order to better comprehend how the well-known RP-HPLC technology may be applied to meet its intended goals, the factors that affect chromatographic separation are studied in this article. In order to comprehend method variables at different levels, the QbD analytical method development technique was applied. Keywords: Quality by Design, Hydrochlorothiazide, Olmesartan Medoxomil, RP- HPLC, Design Approach
Publication date: 01/02/2024

https://ijbpas.com/pdf/2024/February/MS_IJBPAS_2024_7774.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.2.7774