DEVELOPMENT AND VALIDATION OF THE RP-HPLC METHOD FOR ESTIMATION OF CILNIDIPINE IN RAT PLASMA

Abstract

Objective: A simple, precise, accurate, robust, and reliable RP-HPLC technique for detecting cilnidipine in Wistar rat plasma was developed and validated. Methods: The chromatographic separation was performed using the C-18 reverse phase column Oyster BDS Premium C18 column (4.6 × 150 mm, 5 µm particle size). The flow rate was set to 1.2 ml/min, and the chromatogram was recorded at 240 nm. The proposed method was validated in compliance with the International Conference on Harmonization (ICH) guidelines. Results: The calibration curves plotted were found to be linear over the concentration range of 40-200 ng/ml in Wistar rat plasma, with a regression coefficient of R2>0.999, suggesting that the linearity was within limits. The LOD and LOQ of the present method were found to be 2.184 and 4.518 ng/ml, respectively. Drug extraction recoveries from Wistar rat plasma were found to be >98%. Conclusion: Using Wistar rat plasma, a simple, fast, specific, accurate, and precise analytical approach was developed and validated. The technique was validated according to the ICH guidelines. The obtained results show that the suggested technique can be simply and effectively utilized for routine cilnidipine analysis in Wistar rat plasma.