Method Development and Process Validation of Glucose Estimation in Chewable Tablets by RP-HPLC.

Several analytical procedures use the HPLC method to test glucose in other dosage forms, but there isn't yet for tablet dosage forms. To determine glucose in chewable tablet dosage form using RP-HPLC, we thus concentrate on creating a single efficient approach. This study aims to develop and validate a simple, accurate, rapid, and economical method for glucose chewable tablets by RP-HPLC. The validated method is used to validate the process at each stage of tablet production. Chromatographic runs were carried out on a Bondapak NH2 (10 μm, 3.9 mm x 300 mm) column with a mobile phase of water and acetonitrile (70:30) at a flow rate of 1 mL/min and detected using an RI detector as per ICH guidelines. The method is shown to be linear in the range of 80% (1.6 mg/mL) to 120% (2.4 mg/mL) of operating concentration with a correlation coefficient of 0.999, accurate at a recovery rate of 98.0% and 102.0%, and robust to changes in mobile phase ratio and flow rate. It is a simple, accurate, economical, fast, and precise method for glucose. [ABSTRACT FROM AUTHOR]