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Original Articles Open Access
A stability- indicating ultra Performance liquid chromatography (UPLC) method has been developed and validated for the simultaneous determination of Naproxen and Esomeprozole Magnesium in pharmaceutical preparations. An Agilent Zorbax SB Phenyl column (50X4.6mm i.d., 1.8μm particle size) was used. The mobile phase consisted of a mixture of 10 mm Ammonium Bicarbonate (adjusted to pH 7.0 with Phosphoric acid) and acetonitrile in the ratio 50:50 Ultraviolet (UV) detection was performed at 215 nm. Total run time was 5 min; these two drugs were eluted at the retention times of 0.766 and 1.484 min for Naproxen and Esomeprozole Magnesium respectively. The method was validated in terms of linearity, range, specificity, accuracy, and precision, limit of detection (LOD) and limit of quantitation (LOQ). The linearity for both the drugs was found in the range of 18.7-150 μg mL-1of Nap and 1-8 μg mL-1. The % recoveries of Naproxen were found to be 98.2-100.2% and Esomeprozole Magnesium were found to be 99.8-101.6% . The utility of the procedure is verified by its application to marketed formulations that were subjected to accelerated degradation studies. The method distinctly separated the drug and degradation products even in actual samples. The products formed in marketed tablet dosage forms are similar to those formed during stress studies.
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Author(s): Khagga BhavyasriV Murali Balaram R Nageswarao D Rambabu and M Ajitha
Method development, Validation, Simultaneous, Naproxen sodium and Esomeprozole Magnesium ,Stability-indicating, chromatographic method