Quantification of Levosulpiride in Human Plasma by High‐Performance Liquid Chromatography

Liquid chromatography–tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study

“…The significant overlap of the plasma concentration-time profiles and the equivalence of the pharmacokinetic parameters suggest that the two formulations were bioequivalent and that the test drug was well tolerated. The obtained parameters were in accordance with previous reports [14].…”

“…This procedure proved much simpler than previous LC-MS [20,21] and chromatographic methods [7][8][9][10][11][12][13][14][15]. The amount of plasma used (100 L) was significantly lower than that in previous studies [5][6][7][8][9][10][11][12][13][14][15][16]21]. Earlier studies had shown a relationship between the pH of the sample and the percent recovery of levosulpiride; more basic conditions (pH 11) resulted in a higher recovery of levosulpiride from the plasma [20].…”

“…The use of UPLC allowed separation of analyte and IS from the endogenous matrix within 1.5 min and yielded excellent chromatographic peak shapes with an isocratic mobile phase. The 3-min runtime is considerably shorter than that of previous methods [5][6][7][8][9][10][11][12][13][14][15][16], including LC-MS [20]. Recently, a rapid method was described that afforded elution of analyte and IS within the void volume (0.6 min).…”

“…Several methods, including spectrofluorometry [6], liquid chromatography with fluorescence [7][8][9][10][11][12], and ultraviolet detection [13,14], have been reported for determining levosulpiride levels in human biofluids. High-performance liquid chromatography (HPLC) is a well-established technique, but is limited by poor specificity and long analysis times.…”

Rapid quantification of levosulpiride in human plasma using RP‐HPLC‐MS/MS for pharmacokinetic and bioequivalence study

“…GC/MS techniques were reported early in the development of sulpiride and presented a low sensitivity of 50 ng/mL with time-consuming pre-column derivatization (Frigerio and Pantarotto, 1977). Several HPLC methods coupled with fluorescence detection (Tokunaga et al, 1997;Cho and Lee, 2003;Cho et al, 2004;Jin et al, 2004) and ultraviolet detection (UVD) (Bressolle and Bres, 1985;Koo et al, 2006) were developed. However, these methods possess disadvantages such as long analytical run times or back-extraction procedures for clear separation of levosulpiride, even though they presented sufficiently low lower limits of quantitation (LLOQs) of 0.25-10 ng/mL.…”