Stability indicating reverse phase high-performance liquid chromatographic determination of pioglitazone hydrochloride in pharmaceuticals and human urine

Basavaiah, K. and Rajendraprasad, N. (2017) Stability indicating reverse phase high-performance liquid chromatographic determination of pioglitazone hydrochloride in pharmaceuticals and human urine. Journal of Pharmaceutical and Applied Chemistry, 3 (2). pp. 151-160.

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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-1and 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 viastandard 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 otherstress conditions, thus revealing the stability-indicating ability of the developed method

Item Type:	Article
Uncontrolled Keywords:	Pioglitazone, determination, HPLC, pharmaceuticals, stability-indicating
Subjects:	C Chemical Science > Chemistry
Divisions:	Department of > Chemistry
Depositing User:	C Swapna Library Assistant
Date Deposited:	12 Jun 2019 06:11
Last Modified:	12 Jun 2019 06:11
URI:	http://eprints.uni-mysore.ac.in/id/eprint/2981

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