Development and validation of a highly sensitive LC‐MS/MS method for quantitation of dexlansoprazole in human plasma: application to a human pharmacokinetic study

Hotha, Kishore Kumar; Bharathi, D. Vijaya; Jagadeesh, B.; Ravindranath, L. K.; Veera, K. N. Jaya; Venkateswarulu, V.

doi:10.1002/bmc.1645

Cited by 13 publications

(5 citation statements)

References 15 publications

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“…The safety profile of dexlansoprazole MR is similar to that of lansoprazole. The extended pharmacodynamic effects, added convenience, and efficacy and safety of dexlansoprazole MR offer a novel approach to gastric pH control in patients with acid-related disorders [18][19][20][21][22].…”

Section: Discussionmentioning

confidence: 99%

Comparation of Bioavailability: Two Dexlansoprazole Formulations in Beagle Dogs after a Single Dose Administration

Zhang¹,

Qi²,

Wu³

et al. 2013

J Bioequiv Availab

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The study was performed to determine oral bioequivalence of generic dexlansoprazole and reference formulation (Dexilant) in healthy dogs. A 2 period crossover balanced design was used with a 7 days washout period between the doses. Dexlansoprazole was analyzed by LC-MS/MS in the presence of omeprazole as internal standard. The mean ratio of parameters C max and AUC 0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence. The means AUC 0-t for test and reference formulation were 4094.5 ug/L*h and 3684.9 ug/L*h, for AUC 0-∞ were 4137.5 ug/L*h and 3709.6 ug/L*h and, for C max 1643.0 ug/L and 1498.2 ug/L, respectively. Geometric mean of the test /reference Pharmaceuticals 30 mg formulation individual percent ratio was 99.3% for AUC 0-t , 100.6% for AUC 0-∞ and 110.0% for C max. The 90% confidence intervals were 84.0% ~ 117.5%, 85.3% ~ 118.7%, 85.0% ~ 142.3%, respectively. It was concluded that pharmacokinetic data for test formulation were similar enough to original innovator, both formulations had the delayed releasing and double peak characteristics in dogs according to the rate and extent of absorption.

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Section: Discussionmentioning

confidence: 99%

Comparation of Bioavailability: Two Dexlansoprazole Formulations in Beagle Dogs after a Single Dose Administration

Zhang¹,

Qi²,

Wu³

et al. 2013

J Bioequiv Availab

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“…According to previous studies, S-(−)-lansoprazole is more easily metabolized to pharmacologically inactive 5-hydroxy and sulfone metabolites (Masa, Hamada, Arimori, Fujii, & Nakamo, 2001;Milura et al, 2004). Better yet, R-(+)-lansoprazole elicited enhanced pharmacodynamics activity compared with racemic lansoprazole (Hotha et al, 2012;Kukulka, Eisenberg, & Nudurupati, 2011;Parekh, Oldfield, & Johnson, 2014 10-250 ng/mL) and the use of large volumes of plasma for intricate sample preparations (Cirilli et al, 2009;Jia et al, 2012;Miura, Tada, & Suzuki, 2004). As a consequence of the numerous merits of R-(+)-lansoprazole, such as the slower metabolism, higher plasma concentration, longer elimination half-time and greater systemic exposure, it was developed and approved for marketing as a novel proton-pump inhibitor with the trade name Dexilant in 2009 (Gomes, Cassiano, Pedrazzoli, & Cass, 2010;Hershcovici, Jha, & Fass, 2011;Katsuki, Hamada, Nakamura, Arimori, & Nakano, 2001;Metz, Vakily, & Dixit, 2009).…”

Section: Introductionmentioning

confidence: 97%

Enantioselective analysis of lansoprazole in rat plasma by LC–MS/MS: Application to a stereoselective pharmacokinetic study

Wen

et al. 2018

Biomedical Chromatography

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A rapid, sensitive and enantioselective method was developed and fully validated for the separation and determination of lansoprazole enantiomers in rat plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The analytes and the internal standard (esomeprazole) were both extracted from plasma samples by liquid-liquid extraction with diethyl ether-dichloromethane (70:30; v/v). Satisfactory resolution (R = 2.0) was achieved within 7.3 min on a Chiralpak ID column (250 × 4.6 mm, 5 μm) employing acetonitrile-water (60:40, v/v) as the mobile phase at a flow rate of 0.6 mL/min. The acquisition of mass spectrometric data was performed in the multiple reaction monitoring mode coupled with a positive electrospray ionization source. A comprehensive validation of this method was rigorously conducted over the concentration range of 1.00-500.0 ng/mL for both enantiomers. All of the validation data demonstrated that the desirable linearity, sensitivity, accuracy, precision, recovery and stability were attained from the proposed approach. The established method was successfully applied to a stereoselective pharmacokinetic study of lansoprazole enantiomers in rat plasma after oral administration of 3 mg/kg racemic lansoprazole or dexlansoprazole. No chiral inversion was observed during the experimental procedure.

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“…The literature survey revealed a stability method and an analytical method for Dexlansoprazole (DLP) was estimated by HPLC (Hotha et al, 2012;Sriharshaet al, 2015;Yanamadala et al, 2013) and to best of our knowledge, liquid chromatographytandem mass spectroscopy has been previously reported in human plasma.…”

Section: Introductionmentioning

confidence: 99%

Sensitive Analytical Liquid Chromatography-Tandem Mass Spectroscopy Method for the Estimation of Dexlansoprazole in Pharmaceutical Formulations

Bora¹,

Narenderan²,

Babu³

et al. 2018

J App Pharm Sci

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A sensitive LC-MS/MS method has been developed and validated for the quantitative determination of Dexlansoprazole from the commercially available formulations. Omeprazole was used as the internal standard. Isocratic separation was achieved using Zorbax SB C 18 column (4.6 × 100 mm, 3 µm) as a stationary phase and the mobile phase consists of (0.5 mM) Ammonium Acetate adjusted to pH 3.5: acetonitrile (30:70 V/V) with a flow of 0.5 mL/min. Detection was carried out by triple quadrupole mass spectrometry with electrospray ionization in positive mode with proton adducts at m/z 370.05 to 251.95 and 346.00 to 198.05 to monitor Dexlansoprazole and Omeprazole. The linearity of the method was found over a concentration range of 0.5-3000 ng/mL with a regression analysis of 0.9994. The percentage recovery of the present method was found to be 94.33 to 99.97%. The LC-MS/MS method was validated as per ICH guidelines. The developed method can be successfully applied for the estimation of Dexlansoprazole in the commercial formulation and in bulk drug.

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Development and validation of a highly sensitive LC‐MS/MS method for quantitation of dexlansoprazole in human plasma: application to a human pharmacokinetic study

Cited by 13 publications

References 15 publications

Comparation of Bioavailability: Two Dexlansoprazole Formulations in Beagle Dogs after a Single Dose Administration

Comparation of Bioavailability: Two Dexlansoprazole Formulations in Beagle Dogs after a Single Dose Administration

Enantioselective analysis of lansoprazole in rat plasma by LC–MS/MS: Application to a stereoselective pharmacokinetic study

Sensitive Analytical Liquid Chromatography-Tandem Mass Spectroscopy Method for the Estimation of Dexlansoprazole in Pharmaceutical Formulations

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