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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.

 




 

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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.

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