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Abstract
The objective of the present investigation was to separate, identify and characterize the major degradation products of olopatadine hydrochloride, an anti-allergic drug, generated under different stress conditions as per International Conference on Harmonization (ICH) guidelines Q1A (R2). The drug underwent transformation under acidic, basic, and photolytic stress, whereas it was stable in oxidative and thermal stress conditions. Total five degradation products were formed, which were separated by using HPLC on Inertsil ODS 3 (250 mm × 4.6 mm, 5 µm) column using gradient elution program. A complete mass fragmentation pathway of the drug was first established with the help of LC-MS/TOF accurate mass studies. The stress samples were subjected to LC-MS/TOF studies. The obtained mass spectral data were employed to characterize four degradation products. The products formed under degradation study were identified as 11-[(E)-3-(Dimethylamino) propylidene]-6, 11-dihydrodibenz [b, e] oxepin-2-acetic acid, 2-((Z)-9-(3-(dimethylamino) propylidene)-9H-fluoren-7-yl) acetic acid, 11-[(E)-3-(Dimethylamino) propylidene]-6, 11-dihydrodibenz [b, e] oxepin-2-acetic acid methyl ester, 11-[(Z)-3-(Dimethylamino) propylidene]-6, and 11-dihydrodibenz [b, e] oxepin-2-acetic acid methyl ester. The developed method was successfully used for analysis of formulation.
ACKNOWLEDGMENT
The authors wish to thank DBT-ICT Center for Energy Biosciences, Mumbai, for conducting LC-MS/TOF studies.
Notes
Number of containers = 10, n = 3.