مرکز اطلاعات علمی Scientific Information Database (SID) - Trusted Source for Research and Academic Resources

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1

Information Journal Paper

Title

LC-MS METHOD FOR STUDYING THE PHARMACOKINETICS AND BIOEQUIVALENCE OF CLONIDINE HYDROCHLORIDE IN HEALTHY MALE VOLUNTEERS

Pages

  91-98

Abstract

 Background: A simple and sensitive HIGH PERFORMANCE LIQUID CHROMATOGRAPHY-elec-trospray ionization mass spectrometry method has been evaluated for the assignment of CLONIDINE HYDROCHLORIDE in human plasma.Methods: The mobile phase composed of acetonitrile-water 60:40 (v/v) and 0.2% for-mic acid 20 ml of sample was chromatographically analyzed using a repacked ZOR-BAX-XDB-ODS C18 column (2.1 mm´30 mm, 3.5m). Detection of analytes was achiev-ed by tandem mass spectrometry with Electrospray Ionization (ESI) interface in positive ion mode operated under the multiple-reaction monitoring mode (m/z 230.0 ®213). Sample pretreatment consisted of a one-step Protein Precipitation (PPT) with methanol and perchloric acid (HClO4) of 0.10 ml plasma.Results: Standard curve was linear (r=0.998) over the concentration range of 0.01-10.0 ng/ml and showed suitable accuracy and precision. The Limit of Quantification (LOQ) was 0.01 ng/ml. The mean (SD) Cmax, Tmax, AUCo-t and AUCo-¥ values after administration of the test and reference formulations, respectively, were in this manner: 6.16 (0.32) versus 6.21 (0.07) ng/ml, 30.12 (0.86) versus 30.13 (0.73) hr, 290.37 (1.13) versus 293.39 (1.22) ng/ml/hr, and 350.17 (1.98) versus 352.96 (1.67) ng/ml/hr. The mean (SD) t1/2 was 120.12 (1.90) hr for the test formulation and 120.96 (1.54) hr for the reference formulation. No statistical differences were showed for Cmax and the area under the plasma concentration-time curve for test and reference tablets.Conclusion: The method is rapid, simple, very steady and precise for the separation, assignment, pharmacokinetic and bioavailability evaluation of clonidine in healthy Iranian adult male volunteers.

Cites

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    • Cite

    APA: Copy

    DANAFAR, HOSSEIN, & HAMIDI, MEHRDAD. (2016). LC-MS METHOD FOR STUDYING THE PHARMACOKINETICS AND BIOEQUIVALENCE OF CLONIDINE HYDROCHLORIDE IN HEALTHY MALE VOLUNTEERS. AVICENNA JOURNAL OF MEDICAL BIOTECHNOLOGY (AJMB), 8(2), 91-98. SID. https://sid.ir/paper/313906/en

    Vancouver: Copy

    DANAFAR HOSSEIN, HAMIDI MEHRDAD. LC-MS METHOD FOR STUDYING THE PHARMACOKINETICS AND BIOEQUIVALENCE OF CLONIDINE HYDROCHLORIDE IN HEALTHY MALE VOLUNTEERS. AVICENNA JOURNAL OF MEDICAL BIOTECHNOLOGY (AJMB)[Internet]. 2016;8(2):91-98. Available from: https://sid.ir/paper/313906/en

    IEEE: Copy

    HOSSEIN DANAFAR, and MEHRDAD HAMIDI, “LC-MS METHOD FOR STUDYING THE PHARMACOKINETICS AND BIOEQUIVALENCE OF CLONIDINE HYDROCHLORIDE IN HEALTHY MALE VOLUNTEERS,” AVICENNA JOURNAL OF MEDICAL BIOTECHNOLOGY (AJMB), vol. 8, no. 2, pp. 91–98, 2016, [Online]. Available: https://sid.ir/paper/313906/en

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