Development and validation of stability indicating UPLC method for the simultaneous estimation of triamterene and hydrochlorothiazide in combined dosage forms using quality by design approach

Abstract

Abstract Background According to the information gathered from the literature, no technique for UPLC of triamterene and hydrochlorothiazide employing QbD in the formulations has been published. The technique development by incorporating QbD and validating for accuracy, linearity, precision, LOQ, LOD, ruggedness and selectivity as per ICH is part of the work’s modernity. Results Screening investigations led to the selection of cmps. Peak tailing was evaluated as a metric of technique robustness based on these important analytical attributes, namely retention time. With a 0.1 percent OPN: methanol (40:60) mobile phase, a flow rate of 0.3 ml/min, a wave length of 224 nm, an injection volume of 41, and a run time of 6 min, the best chromatographic separation was attained. Conclusions The method was verified using ICH criteria, which ensure a high level of linearity, accuracy, precision, specificity and robustness. As a result, the suggested approach is regarded as a quick and accurate method for estimating triamterene and hydrochlorothiazide at the same time.

Keywords

• QbD
• UPLC
• OPA
• ICH guidelines
• Triamterene
• Hydrochlorothiazide