Stability Indicating HPLC Method for the Simultaneous Estimation of Triamcinolone Acetonide and Benzyl Alcohol in Pure Form and Epirelefan® Vial

Author Info

Mahmoud M. Sebaiy Sobhy M. El-Adl Mohamed M. Baraka Mostafa S. Mohram Yara M. Elkady

Corresponding Author

Mahmoud M. Sebaiy
Medicinal Chemistry Department, Faculty of Pharmacy, Zagazig University, Sharkia, Egypt

A B S T R A C T

A rapid, sensitive, and accurate stability indicating HPLC method was developed for the simultaneous determination of triamcinolone acetonide and benzyl alcohol in pure form, degradation products and pharmaceutical preparation. The separation was carried out on RP BDS Hypersil® C18 column (150 x 4.60 mm, 5μm) using an isocratic mobile phase composed of acetonitrile: 0.05 M phosphate buffer PH 3.50 (55 : 45). Both benzyl alcohol and triamcinolone acetonide quickly eluted at 1.67 min and 3.42 min, respectively, with a flow rate of 1.50 mL /min and UV detection at 254 nm. The linearity was in the range of 1 – 50 µg/mL for triamcinolone acetonide and 2 - 10 µg/mL for benzyl alcohol. The method has been validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification, robustness, and ruggedness as per the ICH guidelines. Finally, the method was compared statistically with reference methods indicating that there is no significant difference between them in respect of precision and accuracy.

Article Info

Article Type

Research Article

Publication history

Received: Mon 09, Nov 2020
Accepted: Sat 16, Jan 2021
Published: Sat 23, Jan 2021

Copyright

© 2023 Mahmoud M. Sebaiy. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Hosting by Science Repository.
DOI: 10.31487/j.AJMC.2020.01.11