Development and Validation of HPLC Method for the Simultaneous Quantification of Acetaminophen and Tramadol in Combined Pharmaceutical Dosage Forms with UV Detection.
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Date
2015-04
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Abstract
A new high performance liquid chromatography (HPLC) with ultraviolet detection method is
developed for the simultaneous quantification of acetaminophen and tramadol in bulk and in its combined
pharmaceutical dosage form. The chromatographic separation was performed on Waters symmetry C8 column
(250 mm × 4.6 mm I.D., 5 μm particle size) using isocratic elution. The optimized mobile phase consists of
phosphate buffer (pH 6.8) and methanol (80:20, v/v). The eluted analytes are monitored at 215 nm wavelength
using a UV detector. The developed method separates acetaminophen and tramadol within a run time of 6 min. The
developed method was validated as per International Conference of Harmonization guidelines with respect to
linearity, sensitivity (limit of detection and limit of quantification), selectivity, accuracy, precision and robustness.
The developed and validated method was successfully applied to the determination of acetaminophen and tramadol
in combined pharmaceutical dosage forms without any interference from the excipients with good recovery,
precision and accuracy.
Description
Keywords
acetaminophen, tramadol, simultaneous estimation, C8 column, combined dosage form
Citation
Ravisankar Devalaraju, Sridevi Vishnumolakala, Kumari Putta Geetha. Development and Validation of HPLC Method for the Simultaneous Quantification of Acetaminophen and Tramadol in Combined Pharmaceutical Dosage Forms with UV Detection. International Journal of Applied Biology and Pharmaceutical Technology. 2015 Apr-June; 6(2): 174-181.