Dissolution testing has emerged in the pharmaceutical field as a very important tool to characterize drug product performance. Pioglitazone hydrochloride, a frequently prescribed antidiabetic, has no dissolution assay in official monographs. The aim of the study was to develop and validate a dissolution test for the quality control of pioglitazone hydrochloride (PH) tablets containing 15 mg of active pharmaceutical ingredient (API). Results from testing sink conditions and stability at 37 °C show that PH is stable in potassium chloride buffer at pH 1.2, 1.5, 1.8, and in 0.1 N hydrochloric acid. In vitro dissolution tests of PH tablets were performed using different test conditions but always under sink conditions. The effects of filtration and deaeration were evaluated. The most discriminatory test conditions, potassium chloride buffer at pH 1.5 (900 mL at 37 ± 0.5 °C) as dissolution medium, paddle method (Apparatus 2), 75 rpm, and 60 min, were satisfactory. The UV spectrophotometric method for determination of released PH was developed and validated. The method presented linearity (r 2 = 0.999) in the concentration range of 10-60 μg/mL. The recoveries were good, ranging from 96.407% to 100.24%. The intraday and interday precision results were 1.704% and 1.3869% RSD, respectively. The developed dissolution test is adequate for its purpose and can be applied for the quality control of 15-mg PH tablets.

The availability of a discriminatory dissolution method for use in either quality control testing or product evaluation in quality by design trials is mandatory for products intended for the developed market. This study demonstrates the systematic development of a discriminatory dissolution method for etoricoxib, a BCS Class 2 drug exhibiting highly pHdependent solubility. The pH, speed, and apparatus were simultaneously optimized and tested for method variability, reproducibility, and robustness. The discriminative power of the developed method was suitably demonstrated.

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