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A novel RP-HPLC method for analysis of paracetamol, pseudoephedrine, caffeine and chlorpheniramine maleate in pharmaceutical dosage forms

Author(s): Viswanath Reddy Pyreddy1, Useni Reddy Mallu1, Varaprasad Bobbarala2 and Somasekhar Penumajji 3

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 4;
Start page: 1225;
Date: 2011;
Original page

Keywords: Caffeine | Paracetamol | Pseudoephedrine HCl and Chlorpheniramine maleate | RP-HPLC method development and validation

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 overthe 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 analysisof Caffeine, Paracetamol, Pseudoephedrine hydrochloride and Chlorpheniramine maleate in pharmaceutical drug products.

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