STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF POTENTIAL IMPURITIES OF SUMATRIPTAN AND NAPROXEN SODIUM IN FIXED DOSE COMBINATION

摘要

The current publication describes about development, optimization and validation of simultaneous estimation of impurities present in Sumatriptan and Naproxen sodium tablets using High-Performance Liquid Chromatography (HPLC). Perchlorate buffer (contains 1.0 mL/L of Perchloric acid and 4g/L of sodium perchlorate) is used as Elution phase~A along with acetonitrile as Elution phase~B. Step gradient mode elution technique is opted with a flow rate of 1.0 mL/min with ACE 5 C18 PFP 5μ,250 x 4.6mm column. All the probable impurities are well resolved at a satisfactory level, showing resolution more than 1.2 in sensitive robustness conditions for closely eluting peaks. The projected method is appropriate for quantification of SUM and NAP related known and unknown impurities that originate from the life cycle of the combination drug product. Selected quantification wavelength of 230 nm is found suitable for quantification purpose. Impurities show satisfactory responses and did not find any placebo interference at this working wavelength. Linearity data depicts a linear relationship with a coefficient of correlation greater than 0.99. The projected method is validated as per compendia recommendation as mentioned in ICH. The developed method is highly useful for quantification of impurities in Sumatriptan and Naproxen sodium tablets in a single method.