Home | Articles
Published on:November 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(4s):s642-s649
Original Article | doi:10.5530/ijper.53.4s.160

Development and Validation of Genotoxic Impurity in Esomeprazole Magnesium Trihydrate Active Pharmaceutical Ingredient by LC-MS/MS


Authors and affiliation (s):

Suresh Reddy Yelampalli1,*, Venkata Shanmukha Kumar Jagarlapudi1, Useni Reddy Mallu2

1Department of Chemistry, K.L. Educational foundation (Deemed to be K.L. University), Vijayawada, Andhra Pradesh, INDIA.

2Manasa Life Sciences, Hyderabad, Telangana, INDIA.

Abstract:

Objectives: A rapid, sensitive and selective analytical method has been developed and validated by liquid chromatography tandem Mass spectrometry (LC-MS/MS) for the quantification of traces of Cumene Hydroperoxide in Esomeprazole magnesium trihydrate active pharmaceutical ingredient. Materials and Methods: The chromatographic separation was carried out on a Develosil Phenyl phase-UG-5 150 x 4.6mm, 3μm column. The mobile phase consisting of 1% Ammonia solution buffer and acetonitrile, the flow rate was 0.9 mL/min with isocratic elution. Results: The retention time of Cumene Hydroperoxide was found 9.25 mins. The developed method was validated according to ICH guidelines. The system suitability was found 4.8% RSD and the linearity calibration curve was linear over the concentration range of 2.309 ppm to 12.747 ppm (r = 0.999). The intraday and inter-day precision (RSD %) was 2.1% and the obtained recovery (%) was at LOQ to 150% is in between 92.4% to 102.8% respectively. Conclusion: The low RSD values and high recoveries of the method confirms the suitability of the method for quantification of Cumene Hydroperoxide in Esomeprazole magnesium trihydrate API.

Key words: LC-MS/MS, Esomeprazole magnesium trihydrate, Cumene Hydroperoxide, Method validation, ICH guidelines.

 

Articles in PDF, ePUB and Full text are attached to this page. In order to download, print or access these formats you must be logged in.
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.
1 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.




 

Impact Factor

IJPER - An Official Publication of Association of Pharmaceutical Teachers of India is pleased to announce continued growth in the 2019 Release of Journal Citation Reports (source: 2018 Web of Science Data).

 

Impact Factor® as reported in the 2018 Journal Citation Reports® (Clarivate Analytics, 2019): 0.425

User login

CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.
12 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

DOI HISTORY

IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs