Simple, Direct and Stability-Indicating UV Spectrophotometric Assay of Pioglitazone Hydrochloride in Pharmaceuticals

Abstract

Pioglitazone hydrochloride (PGH) is an antihyperglycemic agent used in the treatment of type-2 diabetes mellitus. A simple and straight forward UV-spectrophotometric method is presented for the determination of PGH in bulk drug and tablets by measuring the absorbance of drug solution in 0.1M H2SO4 at 269 nm. A plot of absorbance versus concentration obeyed Beer’s law over 2–36 µg ml-1 concentration range (r = 0.9981) with a molar absorptivity of 8.85 × 103 l mol-1 cm-1. The limits of detection (LOD) and quantification (LOQ) were calculated to be 0.65 and 1.98 µg ml-1, respectively. Intraday accuracy and precision, expressed as %RE and %RSD, were upto 2.0 and upto1.45, respectively; whereas the respective interday values were upto 2.05 and upto 1.36. The method was validated for robustness and ruggedness as well as selectivity. The method, when applied to the determination of the active ingredient in tablets, yielded percent found values of 98.69±1.18 and 101.2±1.25 for two brands of tablets. Accuracy of the method was checked by recovery study via standard addition procedure, and found to be highly satisfactory. To determine the stability-indicating ability of the developed method, the drug was subjected to acid-, alkali-, peroxide-, heat- and light-induced forced degradation, and determined subsequently by the recommended procedure. Results indicated that the drug was vulnerable to alkali-induced stress condition, but remained intact under other stress conditions.

Keywords: Pioglitazone, determination, UV-spectrophotometry, pharmaceuticals, stabilityindicating

Cite this Article Rajendraprasad N, Basavaiah K. Simple, Direct and Stability-indicating UV Spectrophotometric Assay of Pioglitazone Hydrochloride in Pharmaceuticals. Research & Reviews: A Journal of Pharmaceutical Science. 2017; 8(3): 7–16p.