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HPLC Method Development and Validation for the Quantification of Related Impurities in Testosterone Cypionate Active Pharmaceutical Ingredient

1,2, 3, 1

  1. 1Department of Chemistry, Amity Institute of Applied Sciences, Amity University, Noida, Uttar Pradesh, INDIA.
  2. 2Ipca Laborotaries Ltd., GIDC Estate, Nandesari, Vadodara, Gujarat, INDIA.
  3. 3Fluoro-Agrochemicals Department, CSIR-Indian Institute of Chemical Technology, Tarnaka, Hyderabad, Telangana, INDIA.

CORRESPONDENCE

Amber Bharti

Department of Chemistry, Amity Institute of Applied Sciences, Amity University, Noida, Uttar Pradesh, INDIA.

bharti_amber@rediffmail.com

Received: 18-08-2020; Accepted: 27-09-2021.

Volume 56, Issue 1 · pp. 240-246 · 2022 · DOI: 10.5530/ijper.56.1.28

ABSTRACT

Aim: The purpose of this research study, is to develop and validate a reverse phase HPLC test method for detecting relevant impurities in Testosterone cypionate (TCY).Materials and Methods: The chromatographic system for separation of related impurities were achieved in Zorbax XDB-C8 (15 cm x 4.6 mm), 5 micron HPLC column utilising gradient elution technique. Water was selected as solvent-A and Acetonitrile was preferred as solvent-B for mobile phase. The method is gradient technique. Column heater was kept constant at 35°C; the rate of flow was 1.2 mL per min; volume of injection was 20 μL and 240 nm was set for detector wavelength.Results: The % recovery was in the range of 95.6% to 108.7% for all impurities. The result of correlation coefficient were higher than 0.98. Testosterone is the major degradants obtained from forced degradation study.Conclusion: The created method can be utilise in quality control testing on a regular basis for the analysis of Testosterone cypionate.

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    Bharti, A., Kumbhare, R. M., & Jeyaseelan, C. (2022). HPLC Method Development and Validation for the Quantification of Related Impurities in Testosterone Cypionate Active Pharmaceutical Ingredient. Indian Journal of Pharmaceutical Education and Research, 56(1), 240-246. https://doi.org/10.5530/ijper.56.1.28

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    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0