RP-HPLC method for the quantitative determination of nifedipine in dosage forms, human milk and urine

Nifedipine is antihypertensive and diuretic drug prescribed for angina pectoris, arterial hypertension and Reynaud's phenomenon. This article deals with a simple, feasible and sensitive isocratic Reverse – phase high performance liquid chromatographic method for the determination of nifedipine in bulk drug, pharmaceutical dosage form, in human milk and urine. Chromatographic separation was conducted on prepacked purospher star, C₁₈ (5 μm, 250 x 4.6 mm) column at room temperature using phosphate buffer: acetonitrile (60:40 v/v) as a mobile phase, pH adjusted at 3.0 with orthophosphoric acid at 242 nm. Validation parameters include linearity, accuracy, precision, specificity, limit of detection (LOD), limit of quantification (LOQ) and robustness over a linearity range 2 – 12 μg ml⁻¹according to the ICH guidelines (r □ 0.9991), the inter – day and intra – day precision and relative standard deviation (RSD) □ 1.28%. The system suitability was scrutinized by capacity factor, tailing factor, number of theoretical plates and retention time. The established HPLC method is rapid, accurate and selective, because of its sensitivity and reproducibility