Author(s):
Urvi Das Sharma, Ganesh CH, Ruchi Verma, Lalit Kumar
Email(s):
ruchiverma.pharma@gmail.com
DOI:
10.52711/0974-360X.2023.00980 
Address:
Urvi Das Sharma1, Ganesh CH2, Ruchi Verma1*, Lalit Kumar3
1Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Karnataka, India-576104.
2Celon Labs Pvt. Ltd. ALEAP Industrial Area, Telangana-500090.
3Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 12,
Year - 2023
ABSTRACT:
A High-Performance Liquid Chromatography technique was developed for Residue Analysis of Megestrol Acetate collected from pharmaceutical manufacturing equipment’s. The samples were collected by Texwipe swab, separated by using Primesil C18 150mm x 4.6 mm, 5µm (Part No.: PC181504650) stationary phase and 65:35 of Acetonitrile: water as mobile phase in isocratic mode of elution. The residues were extracted from the swab in ultrasonic bath and later determined at a wavelength of 280nm. The detection was done using PDA detector for improved sensitivity. The developed method was then validated depending on the parameters of Cleaning Validation suggested by FDA. The method was found to be linear in a concentration range of 0.03-15 µg/ml. RSD of six replicates (Precision) were found to be 1% and the Recovery was found to be >90%. This method can be used to determine trace residues by Megestrol Acetate API on the manufacturing equipment’s in order to avoid any cross contamination during batch manufacturing.
Cite this article:
Urvi Das Sharma, Ganesh CH, Ruchi Verma, Lalit Kumar. HPLC Method Development and Validation for Residue Analysis of Steroid. Research Journal of Pharmacy and Technology.2023; 16(12):6039-4. doi: 10.52711/0974-360X.2023.00980
Cite(Electronic):
Urvi Das Sharma, Ganesh CH, Ruchi Verma, Lalit Kumar. HPLC Method Development and Validation for Residue Analysis of Steroid. Research Journal of Pharmacy and Technology.2023; 16(12):6039-4. doi: 10.52711/0974-360X.2023.00980 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2023-16-12-81
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