Research Article | Volume: 8, Issue: 6, June, 2018

A Sensitive, Stability indicating UPLC method for the identification and characterization of forced degradation products for Drometrizole Trisiloxane through MSn studies

M. Ajay Babu G. V. Krishna Mohan J. Satish Pradipbhai D. Kalariya CH. Krishnam Raju Sharad D. Mankumare   

Open Access   

Published:  Jun 29, 2018

DOI: 10.7324/JAPS.2018.8609
Abstract

A rapid, simple and reliable gradient ultra performance liquid chromatography combined with tandem mass spectrometry method was developed and validated for separation, recognition, and characterization of forced degradation products for Drometrizole Trisiloxane. As per International Conference on Harmonization guidelines, the drug was exposed to acidic, basic, photolytic, oxidative and thermal conditions. The main drug shows extensive degradation towards stress conditions such as acid and base hydrolysis. The three degradation products were identified. The chromatographic separation was achieved through the C8 column 2.1 × 100, 1.8 μm) from linear gradient elution and the wavelength detection was set at 305 nm for drug and its forced degradation products. The parameters such as specificity, linearity, accuracy, precision, and robustness were used for validation of the method. The sequential pathway for the fragments was achieved through the acquired mass spectra from drug and its degradation products through LC/MS/MS studies. Accurate masses of drug and its degradation products were confirmed through LC-MS/Q-ToF analysis. Degradation products were characterized by comparing with the pattern of drug molecule fragmentation.


Keyword:     Drometrizole Trisiloxane Stability indicating UPLC Degradation Products Characterization LC-MS/ MS.


Citation:

Babu MA, Mohan GVK, Satish J, Kalariya PD, Raju CHK, Mankumare SD. A Sensitive, Stability indicating UPLC method for the identification and characterization of forced degradation products for Drometrizole Trisiloxane through MSn studies. J App Pharm Sci, 2018; 8(06): 065-074.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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