Development and Validation of a Rapid and Sensitive RP-UPLC Method For Quantitative Determination of Glipizide in Pharmaceutical Dosage Forms

Abstract

Background: A rapid, reliable, efficient, and accurate RP-UPLC method was developed and validated for quantifying Glipizide in commercial samples and tablets. Materials and Methods: Separation was achieved using a BEH C18 column (100 × 2.1mm, 1.8µm) with a mobile phase of 50:50 v/v 0.01 N potassium dihydrogen phosphate buffer and acetonitrile, flowing at 1.0 mL/ min. Detection occurred at 234 nm. Results: Glipizide showed a retention time of approximately 1.25 min with symmetrical peak shapes. The R-squared value (0.999) indicated that this RP-UPLC method is linear throughout the tested concentration range (2.5 - 15 µg/mL). The percent recovery (%) of Glipizide was 99.99%, indicating that the assay was highly accurate. Conclusion: Precision investigations also revealed percent RSD values lower than 1%. The LOD and LOQ are 0.05 µg/mL and 0.14 µg/mL. The validated RP-UPLC technique will be used to conduct routine Quality Control analyses of Glipizide tablets in accordance with ICH criteria.