Bioanalytical Method Development And Validation For Simultaneous Estimation Of Clopidogrel And Pantoprazole | 18760
Journal of Analytical & Bioanalytical Techniques
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A simple, sensitive, rapid, robust and reproducible method for the bioanalytical determination of clopidogrel and
pantoprazole in human plasma was developed using reverse phase high performance liquid chromatographic method.
The analysis was performed on Shimadzu UFLC, C
(250?4.6 mm, 5 μm) column with a mobile phase consisting of 0.03 M
potassium dihydrogen ortho phosphate buffer (pH 3), acetonitrile in the ratio of 40:60 (v/v) with a flow rate of 1.2 mL/min.
The analyte was monitored with UV detector at 240 nm. In the developed method pantoprazole elutes at retention time of
1.9 min and clopidogrel at 5.5 min. The proposed method is having linearity in the concentration range 10-50 μg/ml for both
clopidogrel and pantoprazole. The method was validated with respect to system suitability, linearity, precision, least limit
of detection (LLOD) and least limit of quantification (LLOQ), accuracy (recovery), ruggedness, robustness, stability, forced
degradation studies (specificity). The proposed method can be readily utilized for bulk drug and pharmaceutical formulations
in human plasma (patients) administered with clopidogrel and pantoprazole.
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