Stability indicating analytical method development and validation of eltrombopag olamine in tablet dosage form by RP-UPLC

Ajay I PATEL; Shweta GOSAI; Kajal JADAV; Amit J. VYAS; Ashok B PATEL; Nilesh K PATEL

doi:https://doi.org/10.18596/jotcsa.724484

Article Details

Stability indicating analytical method development and validation of eltrombopag olamine in tablet dosage form by RP-UPLC

Authors:

Ajay I PATEL | Shweta GOSAI | Kajal JADAV | Amit J. VYAS | Ashok B PATEL | Nilesh K PATEL

Publisher:

Turkish Chemical Society

Main Topics:

Analytical chemistry

Journal:

Journal of the Turkish Chemical Society Section A: Chemistry 2020 Vol.7 Issue 3, pp.845-850

Document Type:

Article

Publication Date:

10/2020

Document Language:

English

Document ID (Org No.):

2000502542

Frequency:

Quarterly

eISSN:

2149-0120

DOI:

https://doi.org/10.18596/jotcsa.724484

Abstract:

 

A simple, precise and accurate stability indicating isocratic Reverse Phase Ultra-Performance Liquid Chromatographic (RP-UPLC) method was developed for quantitative determination of Eltrombopag olamine in the presence of degradant products. The method was developed using Acquity UPLC BEH C18 (50 × 2.1 mm, 1.7 μm) column with mobile phase containing a mixture of water (pH 3 with 30 % formic acid) and acetonitrile in ratio 30:70. The eluted compound was monitored at 244 nm and run time was within 2 min. Eltrombopag olamine was subjected to the stress condition of oxidative, acid, base, thermal and photolytic degradation. The drug was found to degrade significantly in acid, base and oxidative stress condition and stable in thermal and photolytic degradation condition. The degradation products were well resolved from main peak, providing stability indicating power of the method. The developed method was validated as per ICH Q2(R1) guideline with Linearity range was between 25-75 μg/ml, % Recovery range was found as 99.8-101.9  and Precision was found as RSD less than 2.

Article Details

Stability indicating analytical method development and validation of eltrombopag olamine in tablet dosage form by RP-UPLC

Authors: Ajay I PATEL | Shweta GOSAI | Kajal JADAV | Amit J. VYAS | Ashok B PATEL | Nilesh K PATEL

Publisher: Turkish Chemical Society

Main Topics: Analytical chemistry

Journal: Journal of the Turkish Chemical Society Section A: Chemistry 2020 Vol.7 Issue 3, pp.845-850

Document Type: Article

Publication Date: 10/2020

Document Language: English

Document ID (Org No.): 2000502542

Frequency: Quarterly

eISSN: 2149-0120

DOI: https://doi.org/10.18596/jotcsa.724484

Issues

Authors:

Ajay I PATEL | Shweta GOSAI | Kajal JADAV | Amit J. VYAS | Ashok B PATEL | Nilesh K PATEL

Publisher:

Turkish Chemical Society

Main Topics:

Analytical chemistry

Journal:

Journal of the Turkish Chemical Society Section A: Chemistry 2020 Vol.7 Issue 3, pp.845-850

Document Type:

Article

Publication Date:

10/2020

Document Language:

English

Document ID (Org No.):

2000502542

Frequency:

Quarterly

eISSN:

2149-0120

DOI:

https://doi.org/10.18596/jotcsa.724484