High performance thin layer chromatographic determination of nifedipine from bulk drug and from pharmaceuticals.
A stability indicating high performance thin layer chromatographic (HPTLC) method for quantification of nifedipine, as bulk drug and from solid oral dosage forms has been developed. The extraction solvent was methanol and the mobile phase was chloroform:ethyl acetate:cyclohexane (19:2:2, v/v/v). The calibration curve of nifedipine in methanol was linear in the concentration range of 180-720 ng. The mean values of correlation coefficient, slope and intercept were 0.995 +/- 1.02, 1.467 +/- 0.56 and 184.16 +/- 2.15. The limit of detection for nifedipine was 20 ng and limit of quantification was 40 ng. No interference was found from photodecomposition products. The percent recovery of nifedipine using the described procedure was 99.08 +/- 1.51. The coefficient of variation for within day and between day analysis was 0.60 and 0.84% for 480 ng and 0.47 and 0.25% for 720 ng nifedipine concentration. The method was utilized to monitor concentration of nifedipine from sustained release marketed solid oral dosage forms as also from the developed sustained release liquid filled and multi unit hard gelatin capsules.
Patravale
V B
VB
Pharmaceutical Division, University Department of Chemical Technology, Matunga, Mumbai, India. vbp@pharma.ucdt.ernet.in
Nair
V B
VB
Gore
S P
SP
D002121:Calcium Channel Blockers / Q000032:analysis*; D002214:Capsules; D002855:Chromatography, Thin Layer; D004355:Drug Stability; D007202:Indicators and Reagents; D000432:Methanol; D009543:Nifedipine / Q000032:analysis*; D012997:Solvents; D013607:Tablets
D002121:Calcium Channel Blockers; D002214:Capsules; D007202:Indicators and Reagents; D012997:Solvents; D013607:Tablets; D009543:Nifedipine; D000432:Methanol