Development and validation of a lc-ms /ms method for the quantitative determination of tramadol hydrochloride

MEDICAL-SURGICAL JOURNAL-REVISTA MEDICO-CHIRURGICALA(2023)

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摘要
The aim of this study was to develop and validated a highly sensitive, accurate, and precise liquid chro-matography and tandem mass spectrometry (LC/MS/MS) method for quantitative analysis of tramadol (TMH) in human plasma using metoprolol tartrate as internal standard (IS). Mate-rial and methods: Quantitative analysis was done with methanol and 0.15 % formic acid in water (40:60, v/v) as the mobile phase and C18 as the stationary phase with a flow rate of 0.5 mL/min and MS as the detector. The mass spectrometer was operated in positive polarity mode. The method was validated for specificity, sensitivity, precision, accuracy, and other analytical parameters. The level of tramadol data was statistically analyzed using ANOVA at a 95% confidence level. Results: The total analytical run time was 2.5 min. The results found were satisfactory over the linear calibration range of 10-500 ng/mL for TMH. It is a simple, fast, precise and accurate liquid chromatographic method. Conclusions: The devel-oped method can be used by scientific community for the quantification of tramadol in plas-ma samples from various clinical studies of different dose strengths.
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tramadol hydrochloride
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