Background: Hypertension represents a widespread cardiovascular condition although usually
asymptomatic, is a major risk factor for myocardial ischemia, renal failure and stroke. Amlodipine is considered
a powerful dihydropyridine calcium channel blocker used as antihypertensive agent. Its mechanism
of action depend on relaxing the smooth muscle of the artery wall and decrease peripheral resistance.
Methods: An accurate, sensitive and robust chiral HPLC method was developed for separation and quantitation
of S(-)- amlodipine simultaneously in the presence of its R(+)- isomer. Chiral separation was applied
using Daicel CROWNPAK CR(+) (5µm, 4.0×150 mm) column which contains (3,3'-diphenyl-1,1'-
binaphthyl)-20-crown-6-ether coated into a 5μm reversed phase silica support. The mobile phase system
was aqueous acidic 70% HClO4 (pH 2.0) and methanol in the proportion of (95:5 v/v), filtered through
0.45 µm membrane and degassed by before use, pumped at a flow rate was 0.8 mL min-1 with UV detector
adjusted at 238 nm.
Results: The chromatographic HPLC method was validated with respect to ICH guidelines. Linear concentration
range was 5-60 µg mL-1 with correlation coefficient (r) about 0.9998, the detection and quantitation
limits was found 1.66 and 5.05 µg m-1; respectively. Accuracy was evaluated using standard addition
technique with mean recovery about 98.40 % while precision was assessed at intraday and interday
level. It was found that all %RSD values below 2%.
Conclusion: A simple, enantioselective, chiral HPLC method was developed and validated for the quantitation
of amlodipine [S-(+)- isomer] in racemic tablets using CROWNPAK CR(+) chiral stationary phase.
The proposed method is specific, precise, accurate, and robust which can be successfully applied for the
routine analysis of S-AML in bulk and pharmaceutical dosage formulations.