Abstract:
Naproxen and Esomeprazole Magnesium Trihydrate are used in combination for
treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The
present work deals with two simple, precise and economical spectrophotometric
methods and one RP-HPLC method for simultaneous estimation of Naproxen and
Esomeprazole Magnesium Trihydrate in combination. In spectrophotometric method
Simultaneous equation method was used. 271 nm and 302 nm were used as analytical
wavelengths. Correlation coefficient was obtained as 0.998 and 0.999 for Naproxen
and Esomeprazole Magnesium Trihydrate, respectively. Second method was first
order derivative method. 269nm (ZCP of Esomeprazole Magnesium Trihydrate and
317 nm (ZCP of Naproxen) as detection wavelength were used for the estimation of
Naproxen and Esomeprazole Magnesium Trihydrate, respectively. Correlation
coefficients obtained were 0.9985 and 0.999 for Naproxen and EsomeprazoleMagnesium Trihydrate, respectively. For both the spectrophotometric methods Beer’s
law was obeyed in the concentration range of 5-50μg/ml and 2-12μg/ml for Naproxen
and Esomeprazole Magnesium Trihydrate, respectively. In RP-HPLC method
efficient chromatographic separation was achieved on Phenomenex luna ODS C18
stationary phase (250mm X 4.6 mm i.d., 5 μm particle size) with simple mobile phase
combination of methanol: water 65:35 (%V/V) in an isocratic mode at a flow rate of
1.2 ml/min at 302 nm. The retention time for Naproxen and Esomeprazole
Magnesium Trihydrate was 3.78±0.06 min and 5.72±0.04 min, respectively. The
calibration curve of Naproxen and Esomeprazole Magnesium Trihydrate was linear in
the range of 5-30 μg/ml (r2=0.9994) and 0.2-1.2 μg/ml (r2=0.9991), respectively.
Proposed methods were validated as per ICH guidelines for linearity, accuracy,
precision and specificity for the estimation of Naproxen and Esomeprazole
Magnesium Trihydrate in combination. All three methods were compared statistically
using ANOVA test. The results were found to be satisfactory, shows the methods can
be used successfully in marketed formulations.
