HPLC method development and validation for the quantification of related impurities in testosterone cypionate active pharmaceutical ingredient
By: Bharti, Amber
.
Contributor(s): Kumbhare, Ravindra Motiram.
Publisher: Karnataka Association of Pharmaceutical Teachers of India (APTI) 2022Edition: Vol.56(1), Jan-Mar.Description: 240-246p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical education and researchSummary: 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.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
|
School of Pharmacy Archieval Section | Not for loan | 2022-1722 |
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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