Development and validation of stability indicating analytical method for Ilaprazole
- Авторлар: Gawande V.1, Singh A.1, Rathor P.1, Damania D.1
-
Мекемелер:
- Department of Pharmaceutical Chemistry, STES’S
- Шығарылым: Том 71, № 6 (2016)
- Беттер: 605-609
- Бөлім: Articles
- URL: https://journals.rcsi.science/1061-9348/article/view/181794
- DOI: https://doi.org/10.1134/S1061934816060162
- ID: 181794
Дәйексөз келтіру
Аннотация
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%.
Негізгі сөздер
Авторлар туралы
Vandana Gawande
Department of Pharmaceutical Chemistry, STES’S
Хат алмасуға жауапты Автор.
Email: gawandevandana848@gmail.com
Үндістан, Pune-41, Maharshtra
Anil Singh
Department of Pharmaceutical Chemistry, STES’S
Email: gawandevandana848@gmail.com
Үндістан, Pune-41, Maharshtra
Piyush Rathor
Department of Pharmaceutical Chemistry, STES’S
Email: gawandevandana848@gmail.com
Үндістан, Pune-41, Maharshtra
Darpan Damania
Department of Pharmaceutical Chemistry, STES’S
Email: gawandevandana848@gmail.com
Үндістан, Pune-41, Maharshtra