Method Development and Validation for Simultaneous Determination of Paracetamol and Ketoprofen by RP – HPLC Technique.

ABSTRACT

The present study describes a simple, accurate and precise RP-HPLC Technique for the simultaneous determination of Paracetamol and Ketoprofen in pharmaceutical dosage form. The method involves an isocratic elution of drug in a stationary phase of YMC, C4 (150 x 4.6 mm, 3 μm) column using a mobile phase composition of methanol and 0.1% (v/v) orthophosphoric acid in the composition ratio of 7030 v/v with a flow rate of 0.9 mL/min at 254nm of detection. The injection volume is 10 μL. the method has been validated for specificity, linearity, range, precision, accuracy, limit of detection, limit of quantification, ruggedness and robustness. The retention times for Paracetamol and Ketoprofen are about 1.50 and 6.27 minutes respectively. Quantitative linearity was observed over the concentration range of 50 to 500 μg/mL for Paracetamol and 20.05 to 200.54 μg/mL for Ketoprofen respectively. The regression equations of concentration of Paracetamol and Ketoprofen are found to be y = 1319x+8671, y = 5280x + 29575 respectively where y is the peak area and x is the concentration of drug (μg/mL). The % recovery of Paracetamol and Ketoprofen are found to be in the range of 97% to104 %. All the validation parameters are within the acceptance range.