Development and Validation of Stability indicating HPLC Method for Determination of Nirogacestat in Bulk and Pharmaceutical Dosage Form
DOI:
https://doi.org/10.48047/z2mej921Keywords:
HPLC, Nirogacestat, Degradation studies, ICH Guidelines.Abstract
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography
(HPLC) method has been developed for the quantitative analysis of Nirogacestat in pharmaceutical dosage
form. Chromatographic separation of Nirogacestat was achieved on Waters alliance e-2695 HPLC, by using
Symmetry shield RP-18 (150 x 4.6 mm, 3.5 µ) column and the mobile phase containing 1.15 gms ammonium
acetate is dissolved in 1lt of HPLC water pH-3.0/OPA & ACN in the ratio of 70:30 % v/v. The flow rate was 1.0
mL/min; detection was carried out by absorption at 269 nm using a photodiode array detector at ambient
temperature. The number of theoretical plates and tailing factor for Nirogacestat were NLT 2000 and should
not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less
than 2.0.
Downloads
Downloads
Published
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation .
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.
