Method Development and Validation for Simultaneous Determination a Multiple Drug Dosage Form of Paracetamol, Phenylepherine and Caffeine by RP-HPLC

Dr. Samson Israel Deta*¹, Dr. Kommana Balaram Kumar², Hayelom G/Kirstos Mangesha^3
1Asst. Prof, Adigrat University, Ethiopia
²Asst.Prof, University of Gondar, Ethiopia
³Lecturer, Adigrat University, Ethiopia

A B S T R A C T
This method describes a procedure to quantify the assay of Paracetamol, Phenylepherine and caffeine tablet using a mobile phase containing containing mixture of 880 mL of sodium perchlorate buffer, 120 mL of acetonitrile and degassed for about 5 minutes in a sonicator.  Paracetamol, Phenylepherine and caffeine is subsequently analyzed by reverse phased HPLC using Phenomenex, Kinetex XB- C18 (100×4.6 mm i.d. 2.6 µm), column. The retention times of Paracetamol, Phenylepherine and caffeine are about 1.2, 1.5, and 2.3 minutes respectively. Quantitative linearity was observed over the concentration range of  81.25 to 487.50µg/mL for Paracetamol 1.25 to 7.5 µg/mL for Phenylepherine and 16.5 to 97.5 µg/mL for Caffeine. The regression equations of concentration of Paracetamol, Phenylepherine and Caffeine are found to be y=7840.x + 32320, y=12582x + 401.8, y=18502x+ 22155 respectively, where y is the peak area and x is the concentrations of drugs (μg/mL). The numbers of theoretical plates obtained were 10123, 5695 and 14288 for Paracetamol, Phenylepherine and Caffeine respectively, which indicates the efficiency of the column.
Keywords: Paracetamol, Phenylepherine and Caffeine, RP-HPLC