Determination of duloxetine in human plasma via LC/MS and subsequent application to a pharmacokinetic study in healthy Chinese volunteers

Determination of duloxetine in human plasma by liquid chromatography with atmospheric pressure ionization–tandem mass spectrometry and its application to pharmacokinetic study

“…The duloxetine hydrochloride as enteric-coated tablet was absorbed slowly in accordance with the characteristic of the enteric-coated dosage form. Pharmacokinetic parameters (T max , C max , AUC 0-t , AUC 0-α , t 1/2 and K e ) were similar between the reference and test products and the AUC agreed with those published pharmacokinetic studies [6].…”

“…Taking into consideration the low levels of duloxetine in plasma, LC-MS-MS method with simple and economic sample preparation method is the first choice for our purpose. The extraction procedure described by Hoja et al is cumbersome and involves multi step extraction; basic extraction, acid back-extraction, acid wash and basic re-extraction [10] and the sample preparation procedure reported in Ma procedure is repeated twice [6]. Besides, a less sample mass onto the column is often preferred in ordinary laboratories for the benefits of both system maintenance and re-injections of the extracted sample when only a limited sample is available.…”

“…To our knowledge, atmospheric pressure ionization (API) source offers some advantages over atmospheric pressure chemical ionization (APCI), GC-NPD and GC-MS in terms of less background noises and suitability for small molecular compounds [7][8][9]. Ma et al described a single-quadrupole mass spectrometry (LC-MS) with selected-ion monitoring (SRM) mode to detect the precursor ion [6]. But in our proposed method, a triple-quadrupole mass spectrometry (LC-MS-MS) with multiple reaction monitoring (MRM) mode was used to detect both the precursor ion and fragment ion.…”

“…A recent survey revealed that few methods were available for the determination of duloxetine in biological samples, which involved HPLC with UV detection, liquid chromatography with single-quadrupole mass spectrometric (LC-MS) method [6], liquid chromatographic-tandem mass spectrometry (LC-MS-MS) with solid phase extraction (SPE) [7,8], gas chromatography-nitrogen-phosphorus detection (GC-NPD) and gas chromatography-mass spectrometry (GC-MS) quantitation [9]. To our knowledge, atmospheric pressure ionization (API) source offers some advantages over atmospheric pressure chemical ionization (APCI), GC-NPD and GC-MS in terms of less background noises and suitability for small molecular compounds [7][8][9].…”

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“…By literature survey, several analytical techniques have been stated for DLX determination in its pure form, pharmaceuticals and bio-fluids, where DLX is not specifically assigned to any pharmaceutical constitution. These techniques include highperformance liquid chromatography, [2,3] liquid chromatography joined with mass spectrometry, [4][5][6] high-performance thinlayer chromatography, [7] spectrofluorimetry, [8] spectrophotometry, [9] and capillary zone electrophoresis. [10] Although these techniques are very sensitive, and not adapted for in situ, and DLX real-time detection also takes a long time, involve expensive devices and skilled technicians are required.…”