Фармацевтика Аналитика Акта

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Simultaneous Determination of NSAID and Antimicrobial Preservatives Using Validated RP-HPLC Method: An Application in Pharmaceutical and Clinical Laboratories

Najmul Hasan, Mathurot Chaiharn, Shabana Naz Shah, Hira Khalid and Abdul Jabbar

A stability indicating, accurate, specific, precise and simple high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Dexibuprofen along with its preservatives i.e. Sodium Benzoate, Methylparaben, and Propylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Acetate Buffer: Acetic Acid (0.1 M) (50:50:0.3 v/v/v) (pH 5.5) was the mobile phase at flow rate 1.0 mL min-1 using a Hibar® μBondapak® C18 column monitored at wavelength of 230 nm. The calibration curve was linear with a correlation coefficient of more than 0.9995 for the drugs. The averages of the absolute and relative recoveries were found to be 100.07%, 99.82%, 99.91% and 99.97% for Dexibuprofen, Sodium Benzoate, Methylparaben and Propylparaben respectively with 5 to 25 ng mL-1 limit of quantification and 1.5 to 7 ng mL-1 limit of detection. The drugs were subjected to stress conditions of hydrolysis (acid, base, oxidation, and thermal degradation). Maximum degradation was observed in base and 35% H2O2 while found almost stable in the other stress conditions. The studies of forced degradation prove the stability indicating power of the method. The developed method was validated in accordance to ICH guidelines. The proposed High-performance liquid chromatographic method was successfully applied to quantify the amount of Dexibuprofen and three most common microbial preservatives in bulk, dosage form and physiological fluid.