Mohana Krishnan, S (2021) Stability Indicating RP-HPLC Method Development and Validation for Related Substances of Testosterone Undecanoate in Capsule Dosage Form. Masters thesis, C. L. Baid Metha College of Pharmacy, Chennai.
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Abstract
In this study, the stability-indicating RP-HPLC based Related substances method was developed for the estimation of Testosterone Undecanoate and its related degradation impurities in capsule dosage form and validated according to ICH guidelines. There are no official compendial methods available for the estimation of Testosterone Undecanoate in both bulk and pharmaceutical dosage forms. This developed gradient RP-HPLC method is found useful in achieving the complete separation and quantification of all possible impurities that could be present after degradation with suitable resolution criteria between the analyte of interest and related impurities. The Optimized chromatographic conditions, summary results of Validation, Degradation results of Sample and API are furnished in Tables 47, 48, 49 & 50 respectively. The Validation and Degradation results were found to be complying with the acceptable limits. Hence the developed method was found to be stability-indicating for the estimation of Testosterone Undecanoate and its related degradation impurities in Capsule dosage form. CONCLUSION: The developed stability-indicating Related Substances method for the determination of Testosterone Undecanoate and its degradation impurities using the RP-HPLC gradient method was found to be simple, accurate, precise, robust, rugged, and specific. Hence this method can be used for routine quality control and stability analysis. Identification and characterization of the impurities present may be taken up as further research in the study.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 261930005 |
| Uncontrolled Keywords: | Stability, RP-HPLC Method, Development, Validation, Substances, Testosterone Undecanoate, Capsule Dosage Form. |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Subramani R |
| Date Deposited: | 03 Nov 2022 15:01 |
| Last Modified: | 03 Nov 2022 15:01 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/20939 |
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