Tramadol

A novel, simple, precise, accurate and reproducible RP-HPLC method was developed and validated for simultaneous estimation of paracetamol, tramadol and dicyclomine in bulk and pharmaceutical formulations. Separation of paracetamol, tramadol and dicyclomine was successfully achieved on a Inertsil ODS C18 (250mm x 4.6mm x 5 µm). The mobile consisted of ammonium acetate buffer (pH 4.5): methanol (80:20 v/v) at a flow rate of 1.0 mL/min. The detection was performed at 271 nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision and robustness. The response was found to be linear in the concentration range of 500 µg/mL to1500 µg/mL for paracetamol; 50µg/mL to150 µg/mL for tramadol; 10 µg/mL to 30 µg/mL for dicyclomine. The LOD and LOQ for paracetamol were found to be 2.712 µg/mL and 9.042 µg/mL, respectively. The LOD and LOQ for tramadol was 0.9009 µg/mL and 3.003 µg/mL, respectively and for dicyclomine it was 0.380 µg/mL and 1.265 µg/mL, respectively.  The percentage recovery for paracetamol, tramadol, and dicyclomine were found to be 99.00%, 100.00% and 99.00%, respectively. The excellent percentage recovery values indicate the high accuracy of the proposed method. The method specifically determines the analytes in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.