| Research Article |
Open Access |
|
| Simple and Validated Method for Estimation of Amlodipine
by LC-MS (ESI) Using Healthy Indian Human Volunteers: and
Evaluation of Pharmacokinetic Parameters |
| Moses Prince Francis*, Selvadurai Muralidharan, Sekar Rajan, Nagarajan and Bhojraj Suresh |
| Department of Pharmaceutical Analysis, J.S.S.College of Pharmacy, Rocklands Ooty, Tamilnadu, India |
| *Corresponding author: |
Dr. Moses Prince Francis,
Department of Pharmaceutical Analysis,
J.S.S.College of Pharmacy,
Rocklands Ooty,
Tamilnadu, India
E-mail: princefrancis4@rediffmail.com |
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| Received April 17, 2010; Accepted June 26, 2010; Published June 26, 2010 |
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| Citation: Moses PF, Muralidharan S, Rajan S, Nagarajan, Suresh B (2010) Simple
and Validated Method for Estimation of Amlodipine by LC-MS (ESI) Using Healthy
Indian Human Volunteers: and Evaluation of Pharmacokinetic Parameters. J
Bioanal Biomed 2: 069-074. doi: 10.4172/1948-593X.1000025 |
| |
| Copyright: © 2010 Moses PF, et al. This is an open-access article distributed under
the terms of the Creative Commons Attribution License, which permits unrestricted
use, distribution, and reproduction in any medium, provided the original author and
source are credited. |
| |
| Abstract |
| A simple and validated liquid chromatographic–mass spectrometric method (LC-MS) for amlodipine in human
plasma was quantifi ed using LC-MS (ESI). Chromatography was performed on a C18 analytical column, the mobile
phase used was Acetonitrile-10mM Ammonium acetate in the ratio of 90:10%v/v and the retention times were 0.829 and
1.281 min for azithromycin (Internal standard) and amlodipine respectively. The ionization was optimized using ESI (+)
and enhanced selectivity was achieved. The method is validated as per FDA guidelines. The analyte was shown to be
stable over the timescale of the whole procedure. The pharmacokinetic parameters such as peak plasma concentration
(Cmax), Time to peak Concentration (tmax), Area under the plasma concentration-time curve (AUC0-t & AUC0-∞), elimination
rate constant (Keli), Elimination half-life (t½) were calculated. Log transferred values were compared by Analysis of
Variance (ANOVA) followed by classical 90% confidence interval for Cmax AUC0-t.and AUC0-∞ and was found to be within
the range. These results indicated that the Test and Reference formulation is bioequivalent. |
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