Development and validation of stability indicating analytical method for Ilaprazole
- 作者: Gawande V.1, Singh A.1, Rathor P.1, Damania D.1
-
隶属关系:
- Department of Pharmaceutical Chemistry, STES’S
- 期: 卷 71, 编号 6 (2016)
- 页面: 605-609
- 栏目: Articles
- URL: https://journals.rcsi.science/1061-9348/article/view/181794
- DOI: https://doi.org/10.1134/S1061934816060162
- ID: 181794
如何引用文章
详细
The objective of the present study was to develop and validate a rapid and simple stability indicating analytical method for estimating Ilaprazole. Ilaprazole was subjected to different stress conditions prescribed by International Conference on Harmonization (ICH) such as hydrolysis, oxidation, photolytic and dry heat degradation conditions. The drug was very susceptible to degradation under hydrolysis and photolytic conditions, less susceptible to oxidation and stable under dry heat degradation condition. An acceptable separation of drug and its degradants was achieved by using a C-18 column and mobile phase composed of ammonium acetate buffer (pH 3.2)—acetonitrile (55: 45, v/v). Flow rate was 1 mL/min and detection wavelength was set at 303 nm. Retention time of drug was found to be 6.6 min and analysis can be completed within 10 min. The method was validated with respect to linearity, precision, accuracy, robustness, LOD and LOQ as per ICH. The method was linear (R2 = 0.996) in the range of 2.5–250 μg/mL. The recovery was in the range from 99.2–100.2%.
作者简介
Vandana Gawande
Department of Pharmaceutical Chemistry, STES’S
编辑信件的主要联系方式.
Email: gawandevandana848@gmail.com
印度, Pune-41, Maharshtra
Anil Singh
Department of Pharmaceutical Chemistry, STES’S
Email: gawandevandana848@gmail.com
印度, Pune-41, Maharshtra
Piyush Rathor
Department of Pharmaceutical Chemistry, STES’S
Email: gawandevandana848@gmail.com
印度, Pune-41, Maharshtra
Darpan Damania
Department of Pharmaceutical Chemistry, STES’S
Email: gawandevandana848@gmail.com
印度, Pune-41, Maharshtra