Development and Validation of Genotoxic Impurity in Esomeprazole Magnesium Trihydrate Active Pharmaceutical Ingredient by LC-MS/MS
1, 1, 2
- 1Department of Chemistry, K.L. Educational foundation (Deemed to be K.L. University), Vijayawada, Andhra Pradesh, INDIA.
- 2Manasa Life Sciences, Hyderabad, Telangana, INDIA.
CORRESPONDENCE
Suresh Reddy Yelampalli
Department of Chemistry, K.L. Educational foundation (Deemed to be K.L. University), Vijayawada, Andhra Pradesh, INDIA.
Received: 05-05-2019; Accepted: 21-09-2019.
Volume 53, Issue 4s (Supplement) · pp. s642-s649 · 2019 · DOI: 10.5530/ijper.53.4s.160
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.
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Yelampalli, S. R., Jagarlapudi, V. S. K., & Mallu, U. R. (2019). Development and Validation of Genotoxic Impurity in Esomeprazole Magnesium Trihydrate Active Pharmaceutical Ingredient by LC-MS/MS. Indian Journal of Pharmaceutical Education and Research, 53(4s), s642-s649. https://doi.org/10.5530/ijper.53.4s.160
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