International Journal of Drug Development and Research

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A Novel Bioanalytical Rp-HPLC Method Development and Validation for Simultaneous Determination of Amlodipine Besylate on Human Plasma

D Mahendra* and Gunosindhu Chakraborthy

The work carried out on Shimadzu LC-2009 SgimadzuHPLC system equipped with Thermo C18 (150 4.6 mm,5 ) column with mobile phase containing 10 mMpotassium dihydrogen phosphate buffer, pH 6.4: ACN: Water in the ratio 20:70:10 v/v/v (1 ml/min.) and detectionwavelength 231 nm. The retention time of Amlodipine besylate was found to be 4.1 min. The developed bioanalytical method was found to be linear in concentration range of 24-48 ng/ml (R2=0.9913). The precision study revealed that the percentage cumulative variation was within acceptable limit and accuracy study showed the value of mean percent recovery between 101.61%-102.20%. The Amlodipine besylate was stable in human plasma at different storage conditions. The validation parameters of the method met the acceptance criteria. Sufficient stability of both LQC and HQC was shown to allow for completion of sample analysis in clinical trials. From the results, we can conclude that developed bioanalytical method can be used for routine analysis of Amlodipine besylate. A simple, sensitive, Rapid and precise bioanalytical RP-HPLC method was developed for estimation of Amlodipine besylate in human plasma.