Development and Validation of RP-UHPLC Method for Quantification of Gliclazide in Bulk and Pharmaceutical Dosage Form Using Quality-by-Design (QbD) Approach: A Shifting Paradigm

The current research endeavours quality-by-design (QbD)-aided chromatographic techniques for the quantification of gliclazide (GLZ) in bulk and pharmaceutical dosage forms. Analytical QbD was initiated by assigning both an analytical target profile (ATP) and critical analytical attributes (CAAs). Furthermore, risk evaluation studies, along with factor screening studies, helped identify critical method parameters (CMPs). Optimisation was carried out using a 3 2 full factorial design by utilising the identified CMP, that is, flow rate ( X 1) and pH of buffer ( X 2) at three different levels along with evaluation of the selected CAA, that is, the retention time ( Y 1) and the peak area ( Y 2). In addition, the influence of sole and interactive CMPs on CAAs was checked using the data obtained statistically and with response surface plots. The confirmation of significance ( P < 0.05) of the method parameters was determined using analysis of variance (ANOVA). Chromatographic separation was achieved using a stainless-steel C8 column (25 cm × 4 mm) in isocratic elution mode using phosphate buffer (pH 3.4) and HPLC-grade acetonitrile (50:50 v/v) as the eluent. The flow rate was adjusted to 1 mL min −1 and the eluent was detected at 230 nm. The validated method, alongside subsequent stress degradation studies conducted according to the ICH guidelines, further favours it as a highly efficient method for the analysis of regular drugs as well as their degraded products. The method proposed above provided a successful demonstration of the QbD-based approach in developing an extremely sensitive and dependable technique for estimating the GLZ for routine analysis and pre-clinical applications.