Simultaneous Determination of Acetaminophen and Tramadol Impurities in combination product of Acetaminophen and Tramadol Tablets by UPLC with Trifunctional Octadecyl Column

Autor: Murali Krishna, M.V.V.N., Rao, Sumathi V, Venugopal, N.V.S., Mantena, Bhaskara P.V
Zdroj: Analytical Chemistry Letters; September 2015, Vol. 5 Issue: 5 p306-318, 13p
Abstrakt: AbstractA Simple, Precise, Sensitive and time efficient stability indicating reverse phase Ultra Performance Liquid Chromatography (RP-UPLC) method was developed and validated for the simultaneous determination of Acetaminophen and Tramadol impurities present in fixed dose combination product. The components were separated in gradient elution mode using 0.1% Perchloric acid in water and acetonitrile as mobile phase. The column used was Acquity HSS T3 (100 mm x 2.1 mm, 1.8 µ) at a flow rate of 0.5 mL.min−1with 30°C temperature. Quantification was achieved with detection wavelength of 215 nm. The developed method was validated for specificity, linearity, precision, accuracy, sensitivity (LOD & LOQ) and robustness in accordance with International Conference on Harmonisation (ICH) guidelines. The method is rapid, cost effective for the quantitative determination of Acetaminophen and Tramadol impurities in Acetaminophen and Tramadol tablets dosage forms.
Databáze: Supplemental Index