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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

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

Amber Bharti1,2★, Ravindra Motiram Kumbhare3, Christine Jeyaseelan1★ Corresponding author

  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; Revised: 09-08-2021; Accepted: 27-09-2021.

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

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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