Stability Indicating Reverse Phase High-performance Liquid Chromatographic Determination of Pioglitazone Hydrochloride in Pharmaceuticals and Human Urine

Basavaiah, Kanakapura; Rajendraprasad, Nagaraju

doi:10.18576/jpac/030209

Stability Indicating Reverse Phase High-performance Liquid Chromatographic Determination of Pioglitazone Hydrochloride in Pharmaceuticals and Human Urine

Document Type : Original Article

Authors

¹ Department of Chemistry, University of Mysore, Manasagangothri, Mysuru-570 006, Karnataka, India.

² PG Department of Chemistry, JSS College of Arts, Commerce & Science, B N Road, Mysuru-570 025, Karnataka, India.

10.18576/jpac/030209

Abstract

A simple, sensitive, specific and stability-indicating high-performance liquid chromatographic (HPLC) method is presented for the determination of of pioglitazone hydrochloride (PGH) in its tablets. The assay was performed on an Inertsil ODS 3V (250 x 4.6 mm; 5 μm) column using phosphate buffer (pH 3.6)-methanol (60:40 v/v) as mobile phase. The flow rate was 1 mL min-1 and the analyte was monitored at 220 nm. The method provides a linear response over the concentration range 0.1 – 300 μg mL-1 (r = 0.9999). The limits of detection (LOD) and quantification (LOQ) were 0.03 and 0.1 μg mL-1, respectively. The method showed intra-day and inter-day precision of <0.5% (RSD) and an accuracy of <2% (RE). Four variables: column temperature, mobile phase composition, flow rate and wavelength were slightly altered, and these were found to have no impact on the method performance indicating robustness of method. Person-to-person and column-to-column variations were also studied as a part of ruggedness study. The developed method was applied to the determination of PGH in its tablet dosage form with acceptable accuracy (%RE, ≤1.28) and precision (%RSD, ≤2.08). Accuracy was also checked by recovery study via standard addition procedure which yielded a mean recovery of 101.1% with a standard deviation of <0.5%. As a part of stress study, the drug was subjected to acid, base, peroxide, heat and light-induced stress conditions; the results showed slight vulnerability to base-induced stress condition and with no change under other stress conditions, thus revealing the stability-indicating ability of the developed method.

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