RP-HPLC method for the estimation of Lobeglitazone sulphate in pharmaceutical dosage form
Department of Pharmaceutical Analysis, Srikrupa Institute of Pharmaceutical Sciences, Velikatta, Siddipet, Telangana-502277, India.
Research Article
GSC Biological and Pharmaceutical Sciences, 2024, 29(02), 286–298.
Article DOI: 10.30574/gscbps.2024.29.2.0411
Publication history:
Received on 20 September 2024; revised on 18 November 2024; accepted on 21 November 2024
Abstract:
A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Lobeglitazone sulfate in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. Kromasil column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 1% glacial acetic acid and acetonitrile in the ratio of 30 : 70 v/v. The method showed a good linear response in the concentration range of 10-60 μg/ml with correlation coefficient of 0.9990. The flow rate was maintained at 1.0 ml/min and detection was carried out at 254 nm. The retention time was 4.211 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of lobeglitazone sulfate in tablet formulation.
Keywords:
Lobeglitazone sulfate; RP-HPLC; Tablet dosage form; Validation; ICH
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