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Abstract
A high performance thin layer chromatographic method coupled with densitometric analysis has been developed for determination of nifedipine in bulk powder and their pharmaceutical dosage forms. The active substance was extracted from tablets with methanol (mean recovery: 100.4%) and chromatographed on silica gel 60 F254 HPTLC plates in horizontal chambers with n‐hexane–ethyl acetate–acetone, 6:3:2 (v/v), as mobile phase. UV densitometric quantitation was performed at 335 nm. The calibration curve was constructed in the range from 0.025 to 0.150 µg µL−1 (corresponding to 0.5–3.0 µg spot−1) with good correlation (r≥0.990) and expressed by a second order calibration function. Determination of nifedipine in tablets was characterized by good precision (2.69%<RSD<7.27%) and accuracy (−3.21<RSE<1.12). The HPTLC‐densitometric method was successfully applied for the identification of nifedipine in the presence of its induced degradation products, in the presence of the other calcium channel blockers, and for the identification of this drug in biological matrix.