Paper Key : IRJ************923
Author: Annarapu Mamatha
Date Published: 11 Nov 2024
Abstract
A simple, sensitive, and rapid RP-HPLC method was developed and validated for the quantification of seven potential impurities in naproxen sodium soft gelatin capsules. The separation of impurities from the drug sample matrix was achieved using an Acquity BEH C18 (100 mm 2.1 mm, 1.7 m) column. The optimized mobile phase consisted of 0.1% ortho-phosphoric acid (OPA) in water, pH adjusted to 3.0 with diluted NaOH (mobile phase A), and acetonitrile (mobile phase B). Gradient elution at a flow rate of 0.5 mLmin, with UV detection at 230 nm, successfully separated the impurities. The column temperature was maintained at 50C, with an injection volume of 3 L and a total run time of approximately 13 minutes. The method was validated in accordance with ICH Q2(R1) guidelines for linearity, specificity, accuracy, LOD, LOQ, precision, robustness, ruggedness, and solution stability. The validated method is stability-indicating and robust, making it suitable for determining impurities that may arise during the shelf life of the drug product. This method is beneficial for quality control laboratories, providing precise results with a shorter run time, enabling faster analysis.
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