Bioanalytical Rp-HPLC Method Development and Validation of Clopidogrel Bisulfate in Wistar Rat Plasma and Its Application to Pharmacokinetic Study

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.

Development of Quantitative Method of Tulobuterol Hydrochloride in Rat Plasma: Validation and Application to Preclinical Pharmacokinetics

“…The robustness appertaining developed method for tulobuterol hydrochloride was deliberated by discretely varying the flow rate (±0.2 ml/min) of the mobile phase as mentioned in the methodology; further retention times were evaluated. The %RSD was within 2%, which revealed robustness and reliability of the developed method [21].…”

“…The peak areas of spiked plasma and blank samples were compared. If there exists any interference with the retention time of tulobuterol hydrochloride, the peak area of the blank should be within 20 % peak area of the tulobuterol peak [20,21].…”

Validation, Stability Studies, and Simultaneous Estimation of Co-Encapsulated Curcumin, Epigallocatechin Gallate Nanoformulation by Rp-HPLC Method

“…The LOQ value were 7.53 µg/ml for EGCG and 3.05 µg/ml for curcumin. These low values demonstrated that the developed method was very sensitive to quantifying EGCG and curcumin [39].…”

Bioanalytical Method Development and Validation of Maralixibat in Rat Plasma by Lc-MS/MS Detection and Its Application to a Pharmacokinetic Study

“…Through the calculation of within and between batch fluctuations at 4 QC sample levels (5.00, 25.00, 50.00, and 75.00 ng/ml) in 6 repetitions, the accuracy and precision of this approach were maintained under control [20,21]. Table 2 shows maralixibat's findings for accuracy and precision.…”