Original ArticleIndian Journal of Pharmaceutical Education and ResearchVol. 56 | Issue 1 | 2022 | pp. 240–246Open access
HPLC Method Development and Validation for the Quantification of Related Impurities in Testosterone Cypionate Active Pharmaceutical Ingredient
- 1,2*,
- 3,
- 1
- 1 Department of Chemistry, Amity Institute of Applied Sciences, Amity University, Noida, Uttar Pradesh, INDIA.
- 2 Ipca Laborotaries Ltd., GIDC Estate, Nandesari, Vadodara, Gujarat, INDIA.
- 3 Fluoro-Agrochemicals Department, CSIR-Indian Institute of Chemical Technology, Tarnaka, Hyderabad, Telangana, INDIA.
Published in Indian Journal of Pharmaceutical Education and Research
Correspondence: Amber Bharti
Department of Chemistry, Amity Institute of Applied Sciences, Amity University, Noida, Uttar Pradesh, INDIA.; Ipca Laborotaries Ltd., GIDC Estate, Nandesari, Vadodara, Gujarat, INDIA.
Email: bharti_amber@rediffmail.com
Copyright: © 2022 Manuscript Technomedia. This is an open access article.
- Published:
- Jan 1, 2022
- Received:
- Aug 18, 2020
- Accepted:
- Sep 27, 2021
- DOI:
- 10.5530/ijper.56.1.28
How to cite
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
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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Article metadata
| Title | HPLC Method Development and Validation for the Quantification of Related Impurities in Testosterone Cypionate Active Pharmaceutical Ingredient |
|---|---|
| Authors | Amber Bharti; Ravindra Motiram Kumbhare; Christine Jeyaseelan |
| Affiliations | Department of Chemistry, Amity Institute of Applied Sciences, Amity University, Noida, Uttar Pradesh, INDIA.; Ipca Laborotaries Ltd., GIDC Estate, Nandesari, Vadodara, Gujarat, INDIA.; Fluoro-Agrochemicals Department, CSIR-Indian Institute of Chemical Technology, Tarnaka, Hyderabad, Telangana, INDIA. |
| Corresponding author | bharti_amber@rediffmail.com |
| Journal | Indian Journal of Pharmaceutical Education and Research |
| Volume / Issue | Vol. 56, Issue 1 (2022) |
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