Abstract
A simple, sensitive and rapid RP-UPLC method was developed and validated for quantification of seven potential impurities of Naproxen sodium in Naproxen sodium soft gelatin capsules. The separation of impurities from drug sample matrix is achieved by Acquity BEH C18 (100 mm × 2.1 mm) 1.7 µ column. The optimized Mobile phase A consists of 0.1 % OPA in water, pH adjusted to 3.0 by using diluted NaoH, for Mobile phase B acetonitrile is used. The Separation of impurities achieved using gradient elution mode at 0.5 mL/min flow rate with working wavelength of 230 nm. The column temperature maintained at 50°C. The Injection volume fixed at 3 µL and run time is about 13 minutes. The developed RP-UPLC method is validated according to the International Conference on Harmonization analytical procedures and methodology Q2(R1) for, linearity, specificity accuracy, LOD, LOQ, precision, robustness, ruggedness and solution stability. Validated method is robust and stability indicating for the determination of all impurities which may arise during shelf life of the drug product. This method is useful in quality control laboratories to generate precise results in faster rate due to its shorter run time.
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