A NEW METHOD DEVELOPMENT AND VALIDATION BY RP-UPLC FOR THE SIMULTANEOUS ESTIMATION OF NAPROXEN AND ESOMEPRAZOLE IN BULK AND PHARMACEUTICAL DOSAGES FORMS

Kiran Kumar A.*, Balakrishnan M. and Chandrasekhar Kothapalli Banooth

ABSTRACT

A new validated RP-UHPLC method has been investigated and developed for the estimation of Naproxen and Esomeprazole simultaneously. The instrument used for the determination is UHPLC_AGILENT_1220 INFINITY LC with UHPLC(WATERS)_SYMMETRY® C18 (4.6x75mm) 3.5μm column. The mobile phase used is phosphoric acid buffer (pH 6.8, adjusted with NaOH), Acetonitrile and Methanol (70:20:10). The UV detection Wavelength selected is 302nm. The total run time is five minutes with 0.6ml/min flow rate. The two drugs Naproxen and Esomeprazole were retained at 1.8min and 3.1min respectively. The correlation coefficients for the selected drugs are 0.999 with a linearity of 18-48 μg/mL for Naproxen and 0.72-1.92 μg/mL for Esomeprazole. The mean recovery percentage is 99.78 & 101.13 for the two drugs. The LOD & LOQ for Naproxen is 0.0298 and 0.1192 where as for Esomeprazole is 0.0108 and 0.0436 μg/mL. According to ICH guide lines the method is validated for its Accuracy, Precession, Linearity, Robustness, Ruggedness, Recovery studies. The developed method is applied satisfactorily for the determination of Naproxen and Esomeprazole in Marketed formulations and in API without interference. All the data are validated statistically and the results are within the prescribed limits.

Keywords: Naproxen, Esomeprazole, Simultaneous estimation, ICH guidelines.