ABSTRACT

This research describes the development and validation of an RP-HPLC method for assaying Hydrochlorothiazide (HZ) and Telmisartan (TEL). Optimization was done by response surface methodology, applying a three-level Box Behnken design. Three factors selected were mobile phase, flow rate, and resolution. Chemsil C18 (4.6 x 250mm, 5?m) was used for chromatography. The mobile phase was 55:45% v/v OPA:ACN (pH 2.5 adjusted with 0.1% TEA). All events were detected at 282 nm using isocratic elution at 1.2 mL/min. The retention time of HZ and TEL were found to be 2.6 min and 5.5 min, respectively. The specificity, linearity, accuracy, precision, limit of detection, the limit of quantitation, and system suitability were examined. HZ and TEL had linear calibration curves between 20-60 ?g/mL, and their correlation coefficients (r2) were 0.999. The relative standard deviation (RSD) was less than 2%, while HZ and TEL recoveries were 98-100%. HZ and TEL have detection and quantitation limits of 0.79597 and 2.41203 ?g/mL, respectively. The RP-HPLC method that was produced and assessed takes less time and can be used regularly in the industry for quality control and analysis of bulk drugs and products. Keywords: RP-HPLC, Hydrochlorothiazide, Telmisartan, Development, QbD, Validation
Publication date: 01/02/2024

https://ijbpas.com/pdf/2024/February/MS_IJBPAS_2024_7772.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.2.7772