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

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Last updated: 05 Jan 2025

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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-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.

DOI

10.18576/jpac/030209

Keywords

Pioglitazone, Determination, HPLC, Pharmaceuticals, Stability-indicating

Authors

First Name

Kanakapura

Last Name

Basavaiah

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Affiliation

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

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First Name

Nagaraju

Last Name

Rajendraprasad

MiddleName

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Affiliation

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

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Volume

2

Article Issue

1

Related Issue

28202

Issue Date

2016-01-01

Receive Date

2021-10-20

Publish Date

2016-01-01

Page Start

69

Page End

78

Online ISSN

2357-0210

Link

https://jpac.journals.ekb.eg/article_200507.html

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https://jpac.journals.ekb.eg/service?article_code=200507

Order

200,507

Type

Original Article

Type Code

2,018

Publication Type

Journal

Publication Title

Journal of Pharmaceutical and Applied Chemistry

Publication Link

https://jpac.journals.ekb.eg/

MainTitle

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

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Article

Created At

23 Jan 2023