Studies On The Bioequivalence Of L-amlodipine

Hypertension is a common chronic disease in clinic, and it has a lot of harm.Cardiovascular and cerebrovascular diseases are the main direct complications. It is a continuous high blood pressure disease, long-term high blood pressure will lead to stroke, heart disease, vascular tumors, kidney failure and other adverse consequences.It is a kind of arterial hypertension characterized by systemic disease may be associated with heart, blood vessels, kidneys and other organs and brain functional or organic changes.It can be divided into primary hypertension and secondary hypertension. Hypertension causes of the disease can be divided into genetic and environmental aspects.L-amlodipine is an anti-hypertensive drug often used in clinical in recent years.Because of its stable and long time in reducing blood pressure and adverse reactions are not common, it has been widely used in clinic.In order to understand and evaluate the absorption and utilization of the body in vivo, we propose and establisha rapid and sensitive liquid chromatographic-tandem mass spectrometric(LC-MS/MS) method for the concentration of L-amlodipine. That is to determine the content of L-amlodipinein plasmaafter people taking L-amlodipine through LC-MS/MS. The developed methods have been used for non-clinical pharmacokinetics and bioequivalence studies of L-amlodipinein human plasma.In this paper investigate recoveries, matrix effects, linear range and lower limit of quantification, stability by specificity, precision and accuracy specifications toconfirm method of LC-MS / MS.concentration ofL-amlodipineinhuman plasma hasgood linear relationship in 0.5 ~ 500?g·L-1. The RSD values of intra- and inter-day precision were both less than 15%. And endogenous substances do not interfere with the determination of L-amlodipine.This method determines concentration of L- Amlodipine in plasma at different moments of 20 healthy volunteers after they were in a single oral dose of the test formulation L- amlodipine and L- amlodipine reference preparation.We use data processing software calculated the pharmacokinetic characteristics of the data.The main pharmacokinetic parameters are log transformed such as Cmax、Tmax、AUC0-t and so on, then make a further statistical analysis of variance test and a further using the appropriate test methods and confidence intervals for bioequivalence evaluation.According to the results of statistical analysis, the test and reference formulations of L-amlodipine are bioequivalent on the main pharmacokinetic parameters of Cmax,Tmax and AUC0-t.That two kinds of amlodipine formulations have biological equivalence.