Development and validation of new RP-HPLC method for the estimation of ceftriaxone sodium in bulk and pharmaceutical dosage form
Department of Pharmaceutical Analysis, Srikrupa Institute of Pharmaceutical Sciences, Siddipet-502 277 (TS), India.
Research Article
GSC Biological and Pharmaceutical Sciences, 2023, 24(01), 062–071.
Article DOI: 10.30574/gscbps.2023.24.1.0221
Publication history:
Received on 26 April 2023; revised on 10 July 2023; accepted on 13 July 2023
Abstract:
A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of ceftrioxone sodium in parentral dosage form. Chromatographic analysis of the drug was achieved on CYBER LAB HPLC comprising of LC- 100 P pump, a variable wavelength programmable LC-UV100 UV detector and SCL system controller. Flowrosil C18 column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of methanol: water : ortho-phosphoric acid in the ratio of (75 :24.5 :0.5 v/v ) . The method showed a good linear response in the concentration range of 10-50 μg/ml with correlation coefficient of 0.9990. The flow rate was maintained at 1.0 ml/min and detection was carried out at 240 nm. The retention time was 3.788 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 ceftrioxone sodium in parentral formulation.
Keywords:
Ceftrioxone; RP-HPLC; Parentral dosage form; ICH; Sensitivity
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