ABSTRACT
OBJECTIVE: To develop a RP-HPLC method for the determination of Caffeine, Paracetamol, Pseudoephedrine hydrochloride and Chlorpheniramine maleate in
pharmaceutical products.METHOD: HPLC analysis was carried out by using a C18 (150mm, 4.6mm and 3μm) column with gradient program. Mobile phase composed
of sol-A: phosphate buffer (1.0g of KH2PO4 in to 1000ml of HPLC water and mixed) and sol-B: acetonitrile. Gradient program was 0-5min, sol-A: 94-94; 5-10minsol-
A: 94-86; 10-15min- sol-A: 86-54; 15-17min- sol-A: 54-52; 17-20min- sol-A: 52-94 and 20-25min- sol-A: 94-94. Flow for mobile phase elution is 1.0ml per min;
column oven temperature is maintained at 40°C and measured the absorbance at 210nm. HPLC water is used as diluent.RESULTS: Paracetamol, Pseudoephedrine HCl,
Caffeine and Chlorpheniramine maleate were eluted at 6.5min, 9.7min, 12.0min and 16.2min, respectively. Percent relative standard deviation for five replicate
standard injections area is below 1.5. The method was validated with specificity, precision, linearity, accuracy, ruggedness and robustness. The response was linear over
the concentration range of 10 to 60 μg per mL for each ingredient, with correlation coefficients value is greater than 0.999. Recovery results were between 98 percent
to 102 percent. CONCLUSION: The developed RP-HPLC method is single and reproducible, with high resolution and has been successfully applied for the analysis
of Caffeine, Paracetamol, Pseudoephedrine hydrochloride and Chlorpheniramine maleate in pharmaceutical drug products.
Key words: Caffeine, Paracetamol, Pseudoephedrine HCl and Chlorpheniramine maleate, RP-HPLC method development and validation.