Quantification of Nimesulide in Human Plasma by High-Performance Liquid Chromatography with Ultraviolet Detector (HPLC-UV): Application to Pharmacokinetic Studies in 28 Healthy Korean Subjects
Nimesulide is a selective COX-2 inhibitor that is as effective as the classical non-acidic nonsteroidal anti-inflammatory drugs in the relief of various pain and inflammatory conditions, but is better tolerated with lower incidences of adverse effects than other drugs. After oral dose of 100 mg nime...
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| Published in | Journal of chromatographic science Vol. 50; no. 5; pp. 396 - 400 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
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Niles, IL
Oxford University Press
01.05.2012
Preston Publications |
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| Abstract | Nimesulide is a selective COX-2 inhibitor that is as effective as the classical non-acidic nonsteroidal anti-inflammatory drugs in the relief of various pain and inflammatory conditions, but is better tolerated with lower incidences of adverse effects than other drugs. After oral dose of 100 mg nimesulide to western subjects, a mean maximal concentration (Cmax) of 2.86 ∼ 6.5 µg/mL was reached at 1.22 ∼ 2.75 h and mean t1/2β of 1.8 ∼ 4.74 h. This study developed a robust method for quantification of nimesulide for the pharmacokinetics and suitability of its dosage in Korea and compared its suitability with other racial populations. Nimesulide and internal standard were extracted from acidified samples with methyl tert-butyl ether and analyzed by high-performance liquid chromatography with ultraviolet detection (HPLC-UV). The 28 healthy volunteers took 2 tablets of 100 mg nimesulide and blood concentrations were analyzed during the 24 h post dose. Several pharmacokinetic parameters were represented: AUC0-infinity = 113.0 mg-h/mL, Cmax = 12.06 mg/mL, time for maximal concentrations (Tmax) = 3.19 h and t1/2β = 4.51 h. These were different from those of western populations as follows: AUC was 14.5% and Cmax was 28% that of of Korean subjects and Tmax and t1/2β were also different. The validated HPLC-UV method was successfully applied for the pharmacokinetic studies of nimesulide in Korean subjects. Because the pharmacokinetics of nimesulide were different from western populations, its dosage regimen needs to be adjusted for Koreans. |
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| AbstractList | Nimesulide is a selective COX-2 inhibitor that is as effective as the classical non-acidic nonsteroidal anti-inflammatory drugs in the relief of various pain and inflammatory conditions, but is better tolerated with lower incidences of adverse effects than other drugs. After oral dose of 100 mg nimesulide to western subjects, a mean maximal concentration (C(max)) of 2.86 ∼ 6.5 µg/mL was reached at 1.22 ∼ 2.75 h and mean t(1/2β) of 1.8 ∼ 4.74 h. This study developed a robust method for quantification of nimesulide for the pharmacokinetics and suitability of its dosage in Korea and compared its suitability with other racial populations. Nimesulide and internal standard were extracted from acidified samples with methyl tert-butyl ether and analyzed by high-performance liquid chromatography with ultraviolet detection (HPLC-UV). The 28 healthy volunteers took 2 tablets of 100 mg nimesulide and blood concentrations were analyzed during the 24 h post dose. Several pharmacokinetic parameters were represented: AUC(0-infinity) = 113.0 mg-h/mL, C(max) = 12.06 mg/mL, time for maximal concentrations (T(max)) = 3.19 h and t(1/2β) = 4.51 h. These were different from those of western populations as follows: AUC was 14.5% and C(max) was 28% that of of Korean subjects and T(max) and t(1/2β) were also different. The validated HPLC-UV method was successfully applied for the pharmacokinetic studies of nimesulide in Korean subjects. Because the pharmacokinetics of nimesulide were different from western populations, its dosage regimen needs to be adjusted for Koreans.Nimesulide is a selective COX-2 inhibitor that is as effective as the classical non-acidic nonsteroidal anti-inflammatory drugs in the relief of various pain and inflammatory conditions, but is better tolerated with lower incidences of adverse effects than other drugs. After oral dose of 100 mg nimesulide to western subjects, a mean maximal concentration (C(max)) of 2.86 ∼ 6.5 µg/mL was reached at 1.22 ∼ 2.75 h and mean t(1/2β) of 1.8 ∼ 4.74 h. This study developed a robust method for quantification of nimesulide for the pharmacokinetics and suitability of its dosage in Korea and compared its suitability with other racial populations. Nimesulide and internal standard were extracted from acidified samples with methyl tert-butyl ether and analyzed by high-performance liquid chromatography with ultraviolet detection (HPLC-UV). The 28 healthy volunteers took 2 tablets of 100 mg nimesulide and blood concentrations were analyzed during the 24 h post dose. Several pharmacokinetic parameters were represented: AUC(0-infinity) = 113.0 mg-h/mL, C(max) = 12.06 mg/mL, time for maximal concentrations (T(max)) = 3.19 h and t(1/2β) = 4.51 h. These were different from those of western populations as follows: AUC was 14.5% and C(max) was 28% that of of Korean subjects and T(max) and t(1/2β) were also different. The validated HPLC-UV method was successfully applied for the pharmacokinetic studies of nimesulide in Korean subjects. Because the pharmacokinetics of nimesulide were different from western populations, its dosage regimen needs to be adjusted for Koreans. Nimesulide is a selective COX-2 inhibitor that is as effective as the classical non-acidic nonsteroidal anti-inflammatory drugs in the relief of various pain and inflammatory conditions, but is better tolerated with lower incidences of adverse effects than other drugs. After oral dose of 100 mg nimesulide to western subjects, a mean maximal concentration (Cmax) of 2.86 ∼ 6.5 µg/mL was reached at 1.22 ∼ 2.75 h and mean t1/2β of 1.8 ∼ 4.74 h. This study developed a robust method for quantification of nimesulide for the pharmacokinetics and suitability of its dosage in Korea and compared its suitability with other racial populations. Nimesulide and internal standard were extracted from acidified samples with methyl tert-butyl ether and analyzed by high-performance liquid chromatography with ultraviolet detection (HPLC-UV). The 28 healthy volunteers took 2 tablets of 100 mg nimesulide and blood concentrations were analyzed during the 24 h post dose. Several pharmacokinetic parameters were represented: AUC0-infinity = 113.0 mg-h/mL, Cmax = 12.06 mg/mL, time for maximal concentrations (Tmax) = 3.19 h and t1/2β = 4.51 h. These were different from those of western populations as follows: AUC was 14.5% and Cmax was 28% that of of Korean subjects and Tmax and t1/2β were also different. The validated HPLC-UV method was successfully applied for the pharmacokinetic studies of nimesulide in Korean subjects. Because the pharmacokinetics of nimesulide were different from western populations, its dosage regimen needs to be adjusted for Koreans. Nimesulide is a selective COX-2 inhibitor that is as effective as the classical non-acidic nonsteroidal anti-inflammatory drugs in the relief of various pain and inflammatory conditions, but is better tolerated with lower incidences of adverse effects than other drugs. After oral dose of 100 mg nimesulide to western subjects, a mean maximal concentration (C(max)) of 2.86 ∼ 6.5 µg/mL was reached at 1.22 ∼ 2.75 h and mean t(1/2β) of 1.8 ∼ 4.74 h. This study developed a robust method for quantification of nimesulide for the pharmacokinetics and suitability of its dosage in Korea and compared its suitability with other racial populations. Nimesulide and internal standard were extracted from acidified samples with methyl tert-butyl ether and analyzed by high-performance liquid chromatography with ultraviolet detection (HPLC-UV). The 28 healthy volunteers took 2 tablets of 100 mg nimesulide and blood concentrations were analyzed during the 24 h post dose. Several pharmacokinetic parameters were represented: AUC(0-infinity) = 113.0 mg-h/mL, C(max) = 12.06 mg/mL, time for maximal concentrations (T(max)) = 3.19 h and t(1/2β) = 4.51 h. These were different from those of western populations as follows: AUC was 14.5% and C(max) was 28% that of of Korean subjects and T(max) and t(1/2β) were also different. The validated HPLC-UV method was successfully applied for the pharmacokinetic studies of nimesulide in Korean subjects. Because the pharmacokinetics of nimesulide were different from western populations, its dosage regimen needs to be adjusted for Koreans. Nimesulide is a selective COX-2 inhibitor that is as effective as the classical non-acidic nonsteroidal anti-inflammatory drugs in the relief of various pain and inflammatory conditions, but is better tolerated with lower incidences of adverse effects than other drugs. After oral dose of 100 mg nimesulide to western subjects, a mean maximal concentration (C sub(max)) of 2.86 similar to 6.5 mu g/mL was reached at 1.22 similar to 2.75 h and mean t sub(1/2 beta ) of 1.8 similar to 4.74 h. This study developed a robust method for quantification of nimesulide for the pharmacokinetics and suitability of its dosage in Korea and compared its suitability with other racial populations. Nimesulide and internal standard were extracted from acidified samples with methyl tertbutyl ether and analyzed by high-performance liquid chromatography with ultraviolet detection (HPLC-UV). The 28 healthy volunteers took 2 tablets of 100 mg nimesulide and blood concentrations were analyzed during the 24 h post dose. Several pharmacokinetic parameters were represented: AUC sub(0-infinity) = 113.0 mg-h/mL, C sub(max) = 12.06 mg/mL, time for maximal concentrations (T sub(max)) = 3.19 h and t sub(1/2 beta ) = 4.51 h. These were different from those of western populations as follows: AUC was 14.5% and C sub(max) was 28% that of of Korean subjects and T sub(max) and t sub(1/2 beta ) were also different. The validated HPLC-UV method was successfully applied for the pharmacokinetic studies of nimesulide in Korean subjects. Because the pharmacokinetics of nimesulide were different from western populations, its dosage regimen needs to be adjusted for Koreans. |
| Author | Kim, Sang-Yeon Kang, Ju-Seop Kim, Youn-Hee Yang, Seok-Chul Lee, Min-Ho Park, Yoo-Sin Kim, Do-Wan Kim, Mi-Sun Kim, Shin-Hee |
| Author_xml | – sequence: 1 givenname: Mi-Sun surname: Kim fullname: Kim, Mi-Sun organization: 1 Department of Dermatology, Eulji Medical Center, College of Medicine, Seoul 139-872, South Korea – sequence: 2 givenname: Yoo-Sin surname: Park fullname: Park, Yoo-Sin organization: 2 Department of Pharmacology & Clinical Pharmacology Lab, College of Medicine; Division of Molecular Therapeutics Development, Hanyang Biomedical Research Institute; Department of Bioengineering, College of Engineering, Hanyang University, Seoul 133-791, South Korea – sequence: 3 givenname: Shin-Hee surname: Kim fullname: Kim, Shin-Hee organization: 2 Department of Pharmacology & Clinical Pharmacology Lab, College of Medicine; Division of Molecular Therapeutics Development, Hanyang Biomedical Research Institute; Department of Bioengineering, College of Engineering, Hanyang University, Seoul 133-791, South Korea – sequence: 4 givenname: Sang-Yeon surname: Kim fullname: Kim, Sang-Yeon organization: 2 Department of Pharmacology & Clinical Pharmacology Lab, College of Medicine; Division of Molecular Therapeutics Development, Hanyang Biomedical Research Institute; Department of Bioengineering, College of Engineering, Hanyang University, Seoul 133-791, South Korea – sequence: 5 givenname: Min-Ho surname: Lee fullname: Lee, Min-Ho organization: 3 Department of Internal Medicine, College of Medicine, Hanyang University, Seoul 133-791, South Korea – sequence: 6 givenname: Youn-Hee surname: Kim fullname: Kim, Youn-Hee organization: 4 Heartscan Healthcare, Kangnam-Gu, Seoul 135-090, South Korea – sequence: 7 givenname: Do-Wan surname: Kim fullname: Kim, Do-Wan organization: 2 Department of Pharmacology & Clinical Pharmacology Lab, College of Medicine; Division of Molecular Therapeutics Development, Hanyang Biomedical Research Institute; Department of Bioengineering, College of Engineering, Hanyang University, Seoul 133-791, South Korea – sequence: 8 givenname: Seok-Chul surname: Yang fullname: Yang, Seok-Chul email: jskang@hanyang.ac.kr organization: 6 Department of Internal Medicine, Seoul National University Hospital, Seoul 110-744, South Korea – sequence: 9 givenname: Ju-Seop surname: Kang fullname: Kang, Ju-Seop email: jskang@hanyang.ac.kr organization: 2 Department of Pharmacology & Clinical Pharmacology Lab, College of Medicine; Division of Molecular Therapeutics Development, Hanyang Biomedical Research Institute; Department of Bioengineering, College of Engineering, Hanyang University, Seoul 133-791, South Korea |
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| Keywords | Human Validation Prostaglandin-endoperoxide synthase Biological fluid Chemical analysis Healthy subject Enzyme Liquid liquid extraction Oral administration Enzyme inhibitor HPLC chromatography Solvent extraction Blood Blood plasma Non steroidal antiinflammatory agent Analgesic Ultraviolet detector Sample preparation Antipyretic Oxidoreductases Nimesulide Pharmacokinetics Quantitative analysis |
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| Title | Quantification of Nimesulide in Human Plasma by High-Performance Liquid Chromatography with Ultraviolet Detector (HPLC-UV): Application to Pharmacokinetic Studies in 28 Healthy Korean Subjects |
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