Abstract
Objective: A novel, simple, precise, accurate, sensitive, and reproducible HPLC method for determining clopidogrel bisulfate in Wistar rat plasma was developed and validated. Methods: The chromatographic separation was performed using Xterra C18 (250 x 4.6 mm, 5μ) column. Mobile phase composed of Acetonitrile ACN: 0.05M potassium dihydrogen orthophosphate buffer pH 4.2 and in the ratio of 75:25% v/v at a flow rate of 1.2 ml/min. Detection was carried out using a PDA detector at 220 nm. The bioanalytical clopidogrel method was validated as per ICH guidelines. Results: The selected chromatographic condition was found to efficiently separate clopidogrel bisulfate (RT-2.838 min). The calibration curve was linear over the concentration range 40-200 ng/ml in Wistar rat plasma with a correlation coefficient of 0.999, respectively. The precision study revealed that the cumulative percentage variation was within the acceptable limit, and accuracy research showed the value of mean percent recovery between 99.72-99.83 %. Conclusion: A simple, rapid, specific, accurate, and precise analytical method was developed and validated using Wistar rat plasma. The technique was strictly validated according to the ICH guidelines. Acquired results demonstrate that the proposed strategy can be effortlessly and advantageously applied for routine analysis of clopidogrel in the Wistar rat plasma.
Highlights
Bioanalysis is the approach used to determine the concentration of drugs and metabolites in the biological matrices like plasma, serum, cerebrospinal fluid, urine, saliva, etc. [1]
The pharmacokinetic calculations were performed on the basis of plasma concentration-time data using PK solver add-in in MS-Excel 2007 [32]
Since clopidogrel is a poorly water-soluble and highly lipophilic compound, it was necessary for the method development to optimize parameters such as choice of organic solvent, pH, the composition of mobile phase,flow rate, and oven temperature
Summary
Bioanalysis is the approach used to determine the concentration of drugs and metabolites in the biological matrices like plasma, serum, cerebrospinal fluid, urine, saliva, etc. [1]. Bioanalysis is the approach used to determine the concentration of drugs and metabolites in the biological matrices like plasma, serum, cerebrospinal fluid, urine, saliva, etc. Bioanalytical methods are essential for bioavailability and bioequivalence studies [2]. Bioanalytical method and validation are utilized to build up that a quantitative analytical approach can be connected for the biochemical process [1, 3]. Validation involves laboratory investigations that the method is suitable and reliable for the intended applications [4]. It is utilized to assess bioavailability and bioequivalence studies, quantitative evaluation of drug and metabolites, new drug development, clinical pharmacokinetics, research process, and therapeutic drug monitoring. Bioanalytical techniques are persistently undergoing changes and improvements that are the cutting edge of technology [5]
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