Capillary isotachophoretic determination of flufenamic, mefenamic, niflumic and tolfenamic acid in pharmaceuticals
Anionic capillary isotachophoresis (ITP) with conductimetric detection has been used for determining selected non-steroid anti-inflammatory and analgesic drugs of the phenamate group, namely tolfenamic ( I), flufenamic ( II), mefenamic ( III) and niflumic ( IV) acid. Initially the p K a values (prot...
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Published in | Journal of pharmaceutical and biomedical analysis Vol. 23; no. 1; pp. 135 - 142 |
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Main Authors | , , |
Format | Journal Article Conference Proceeding |
Language | English |
Published |
Amsterdam
Elsevier B.V
01.08.2000
Elsevier Science |
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Abstract | Anionic capillary isotachophoresis (ITP) with conductimetric detection has been used for determining selected non-steroid anti-inflammatory and analgesic drugs of the phenamate group, namely tolfenamic (
I), flufenamic (
II), mefenamic (
III) and niflumic (
IV) acid. Initially the p
K
a values (proton lost) of
I–
IV were determined as 5.11, 4.91, 5.39 and 4.31, respectively, by the UV spectrophotometry in aqueous 50% (w/w) methanol. The optimised ITP electrolyte system consisted of 10 mM HCl+20 mM imidazole (pH 7.1) as the leading electrolyte and 10 mM 5,5′-diethylbarbituric acid (pH 7.5) as the terminating electrolyte. The driving and detection currents were 100 μA (for 450 s) and 30 μA, respectively (a single analysis took about 20 min). Under such conditions the effective mobilities of
I–
IV varied between 23.6 and 24.6 m
2 V
−1 s
−1 (evaluated with orotic acid as the mobility standard). The calibration graphs relating the ITP zone length to the concentration of the analytes were rectilinear (
r=0.9987–0.9999) in the range 10–100 mg l
−1 of the drug standard. The R.S.D.s were 0.96–1.55% (
n=6) when determining 50 mg l
−1 of the analytes in pure test solutions. The method has been applied to the assay of the phenamates in six commercial mass-produced pharmaceutical preparations (Mobilisin gel and ointment, Lysalgo capsules, Nifluril cream, Niflugel gel, and Clotam capsules). According to the validation procedure based on the standard addition technique the recoveries were 98.4–104.3% of the drug and the R.S.D. values were 1.25–3.32% (
n=6). |
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AbstractList | Anionic capillary isotachophoresis (ITP) with conductimetric detection has been used for determining selected non-steroid anti-inflammatory and analgesic drugs of the phenamate group, namely tolfenamic (
I), flufenamic (
II), mefenamic (
III) and niflumic (
IV) acid. Initially the p
K
a values (proton lost) of
I–
IV were determined as 5.11, 4.91, 5.39 and 4.31, respectively, by the UV spectrophotometry in aqueous 50% (w/w) methanol. The optimised ITP electrolyte system consisted of 10 mM HCl+20 mM imidazole (pH 7.1) as the leading electrolyte and 10 mM 5,5′-diethylbarbituric acid (pH 7.5) as the terminating electrolyte. The driving and detection currents were 100 μA (for 450 s) and 30 μA, respectively (a single analysis took about 20 min). Under such conditions the effective mobilities of
I–
IV varied between 23.6 and 24.6 m
2 V
−1 s
−1 (evaluated with orotic acid as the mobility standard). The calibration graphs relating the ITP zone length to the concentration of the analytes were rectilinear (
r=0.9987–0.9999) in the range 10–100 mg l
−1 of the drug standard. The R.S.D.s were 0.96–1.55% (
n=6) when determining 50 mg l
−1 of the analytes in pure test solutions. The method has been applied to the assay of the phenamates in six commercial mass-produced pharmaceutical preparations (Mobilisin gel and ointment, Lysalgo capsules, Nifluril cream, Niflugel gel, and Clotam capsules). According to the validation procedure based on the standard addition technique the recoveries were 98.4–104.3% of the drug and the R.S.D. values were 1.25–3.32% (
n=6). Anionic capillary isotachophoresis (ITP) with conductimetric detection has been used for determining selected non-steroid anti-inflammatory and analgesic drugs of the phenamate group, namely tolfenamic (I), flufenamic (II), mefenamic (III) and niflumic (IV) acid. Initially the pKa values (proton lost) of I-IV were determined as 5.11, 4.91, 5.39 and 4.31, respectively, by the UV spectrophotometry in aqueous 50% (w/w) methanol. The optimised ITP electrolyte system consisted of 10 mM HCl + 20 mM imidazole (pH 7.1) as the leading electrolyte and 10 mM 5,5'-diethylbarbituric acid (pH 7.5) as the terminating electrolyte. The driving and detection currents were 100 microA (for 450 s) and 30 microA, respectively (a single analysis took about 20 min). Under such conditions the effective mobilities of I-IV varied between 23.6 and 24.6 m2 V(-1) s(-1) (evaluated with orotic acid as the mobility standard). The calibration graphs relating the ITP zone length to the concentration of the analytes were rectilinear (r = 0.9987-0.9999) in the range 10-100 mg l(-1) of the drug standard. The R.S.D.s were 0.96-1.55% (n = 6) when determining 50 mg l(-1) of the analytes in pure test solutions. The method has been applied to the assay of the phenamates in six commercial mass-produced pharmaceutical preparations (Mobilisin gel and ointment, Lysalgo capsules, Nifluril cream, Niflugel gel, and Clotam capsules). According to the validation procedure based on the standard addition technique the recoveries were 98.4-104.3% of the drug and the R.S.D. values were 1.25-3.32% (n = 6). |
Author | Polášek, Miroslav Urbánek, Marek Pospı́šilová, Marie |
Author_xml | – sequence: 1 givenname: M surname: POLASEK fullname: POLASEK, M organization: Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic – sequence: 2 givenname: M surname: POSPISILOVA fullname: POSPISILOVA, M organization: Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic – sequence: 3 givenname: M surname: URBANEK fullname: URBANEK, M organization: Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic |
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Cites_doi | 10.1007/BF02274495 10.1016/0378-4347(92)80486-A 10.1039/a806093b 10.1007/BF02466508 10.1016/S0378-4347(96)00509-9 10.1016/0378-4347(95)00518-8 10.1135/cccc19912964 10.1016/S0731-7085(98)00010-7 10.1016/S0378-4347(97)00674-9 10.1016/0731-7085(93)80196-8 10.1016/0731-7085(86)80068-1 10.1039/an9871201399 10.1016/S0731-7085(98)00227-1 10.1080/10826079508009317 10.1016/0731-7085(94)00090-5 10.1080/00032719608002272 10.1039/an9891400101 10.1080/10826079208020868 10.1016/S0039-9140(98)00086-1 10.1016/0039-9140(95)01789-5 |
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Keywords | Flufenamic acid Niflumic acid Isotachophoresis Pharmaceutical analysis Tolfenamic acid Mefenamic acid Capillary column Cream Ointment Colloidal gel Analysis method Dosage form Hard capsule Quantitative analysis |
Language | English |
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Snippet | Anionic capillary isotachophoresis (ITP) with conductimetric detection has been used for determining selected non-steroid anti-inflammatory and analgesic drugs... |
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SubjectTerms | Analysis Anti-Inflammatory Agents, Non-Steroidal - analysis Biological and medical sciences Calibration Dosage Forms Electrophoresis - methods Flufenamic acid Flufenamic Acid - analysis General pharmacology Isotachophoresis Medical sciences Mefenamic acid Mefenamic Acid - analysis Niflumic acid Niflumic Acid - analysis ortho-Aminobenzoates - analysis Pharmaceutical analysis Pharmaceutical Preparations - chemistry Pharmacology. Drug treatments Reproducibility of Results Tolfenamic acid |
Title | Capillary isotachophoretic determination of flufenamic, mefenamic, niflumic and tolfenamic acid in pharmaceuticals |
URI | https://dx.doi.org/10.1016/S0731-7085(00)00283-1 https://www.ncbi.nlm.nih.gov/pubmed/10898163 https://search.proquest.com/docview/71232758 |
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