Development and validation of RP-HPLC method for estimation of anti- hypothyroidism drug in capsule dosage form
Department of Pharmaceutical Analysis, Aditya Pharmacy College, Beed, Maharashtra, India.
Research Article
World Journal of Biology Pharmacy and Health Sciences, 2023, 15(01), 185–198.
Article DOI: 10.30574/wjbphs.2023.15.1.0322
Publication history:
Received on 14 June 2023; revised on 24 July 2023; accepted on 27 July 2023
Abstract:
A simple, accurate, sensitive and precise Reverse Phase-High Performance Liquid Chromatographic assay method for estimation of Levothyroxine sodium in dosage form was successfully developed. The chromatographic separation was performed on Welch Ultisil XB-CN, 150 x 4.6 mm, 5µm. column. The mobile phase consists of 0.05% OPA Buffer solution, and Acetonitrile in the ratio of 72:28, v/v. Mobile phase was delivered at a flow rate of 1.0 ml/min. Samples were injected 50 μL the column temperature was kept at 40 0C and sample temperature 150C. The wavelength 221 nm were selected for the evaluation of the chromatogram. The retention time of the drug was found to be 3.7 min. The developed method was found to be linear in a concentration range of 5-15 μg/ml of the drug (r2= 0.999). The low value of % RSD indicates reproducibility of the method. Thus this method can be used for routine analysis of pomalidomide in formulation and to check the stability of bulk samples.
Keywords:
Levothyroxine sodium; RP-HPLC; Method validation; Stability indicating assay method
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