Development and Validation of a Simple RP-HPLC Method for Determination of Caffeine in Pharmaceutical Dosage Forms

The present study was undertaken to develop a validated, rapid, simple and economic HPLC method for estimating caffeine in pharmaceutical preparations. Chromatographic determination was performed on a reversed phase C18 column (4.5 mm x 250 mm; 5 μm particle size) using a mixture of water and methanol (60:40) as mobile phase at a flow rate of 1ml/min with UV detection at 272 nm. The method was validated for linearity, accuracy, repeatability, precision, reproducibility, and specificity as per International ICH guidelines. The method was also used in determination caffeine content in five commercial brands available in Bangladeshi market. The method was linear in the range between 12 - 28 μg/ml, exhibited good correlation coefficient (R2 = 0.9992) and good Accuracy study (97.35%-100.02%). The method was found to specific for caffeine in presence of common excipients or in presence of paracetamol in combination dosage form. Statistical analysis performed with proposed method proved it to be precise, accurate and reproducible. Hence it can be employed for routine analysis of caffeine both in bulk and commercial formulations and in combination dosage form with paracetamol.