ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF ZALTOPROFEN AND PARACETAMOL IN THEIR COMBINED SOLID DOSAGE FORM BYRP-HPLC METHODAbstract
A simple, sensitive, linear, precise and accurate RP-HPLC method for simultaneous estimation of Zaltoprofen and Paracetamol in bulk and tablet formulation was developed and validated. The proposed RP-HPLC method utilizes Phenomenex C18 column (150 ×4.6 mm i.d., 5 µm), optimum mobile phase consisted of isocratic run of Phosphate buffer (pH-4.2): acetonitrile (40:60V/V) with the effluent flow rate of 1.0ml/min, and UV detection wavelength 260 nm. The developed method was statistically validated for linearity, precision, robustness, ruggedness and specificity. The method was linear over the range of 2-10 µg/ml for Zaltoprofen and 8-40 µg/ml for Paracetamol. The mean recovery was 99.27% and 99.76% for Zaltoprofen and Paracetamol respectively. The intermediate precision data obtained under different experimental setup was quite concurrent with less critical %RSD. The proposed method can be useful in the quality control of Zaltoprofen and Paracetamol in their combined dosage form.
Dillip Kumar Dash*and Miral Vadher
Department of Quality Assurance, N. R. Vekaria Institute of Pharmacy, Junagadh-362001, Gujarat, India.
03 May, 2014
11 August, 2014
18 August, 2014
01 December 2014