Drug-Drug Interaction Studies of Ibutilide Fumarate with Verapamil and Stability Indicating Method by Chromatographic Techniques
Journal Title: International Journal for Research in Applied Science and Engineering Technology (IJRASET) - Year 2017, Vol 5, Issue 5
Abstract
the aim of the present work is to study interactions of ibutilide fumarate with the antihypertensive drug verapamil at physiological ph 7.4 and temperature 37oc under simulated condition and using commercially procured pooled male rat liver microsomes upto 4 hours. The work also includes the stability of ibutilide fumarate at various stress conditions as recommended by ich guidelines. The hplc(method 1) and hptlc method was developed and validated for the linearity, precision, robustness, limit of detection and limit of quantitation. The linearity was found between 2-16 mcg/ml and 1-9 mcg/spot , the % rsd was found below 1 for interday and intraday precision, lod was found to be 0.5 mcg /ml and 159 ng/spot and loq was found to be 1 mcg/ml and 482 ng/spot for hplc method 1 and hptlc respectively. The validated hplc methods 1 and 2 were applied for the stability indicating method and interaction studies respectively. The ibutilide fumarate was found to be stable at 40 ocand the degradants were above 10% with 0.1m hcl, 0.1m naoh, oxidation, light and at 60 oc. With the increase in time of interaction the ibutilide fumarate concentration varied between 82– 115% with simultaneous variation in the interacting drug verapamil concentration between 25-147% and an additional metabolite peak was found between 43-147% under simulated conditions. The results for the drug ibutilide fumarate with verapamil in the presence of rat liver microsomes containing the cyp3a4 enzymes shows considerable change in the peak area of verapamil . The concentration of ibutilide fumarate shows changes in between 1.156- 108% indicating complete binding with the enzymes when administered as a single drug with additional peaks for the metabolites formed. The verapamil concentration changes within 135-185% in presence of enzymes as a single drug. The change in concentration for ibutilide was found to be 71-106% and for verapamil was found to be 97-300% when both the drugs are co administered.
Authors and Affiliations
Sangeetha R K, Ravi T K
Keywords
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