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A Modified Reverse-Phase HPLC Method for the Analysis of Mexiletine Hydrochloride.

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Title: A Modified Reverse-Phase HPLC Method for the Analysis of Mexiletine Hydrochloride.
Authors: Kaushik, Sarita1 (AUTHOR), Alexander, K.S.1 (AUTHOR) kalexan@utnet.utoledo.edu
Source: Journal of Liquid Chromatography & Related Technologies. Apr2003, Vol. 26 Issue 8, p1287-1296. 10p. 3 Charts.
Subjects: Mexiletine, Liquid chromatography, Vitamin B1, Methanol
Abstract: Mexiletine hydrochloride is an orally active class I antiarrythmic agent. The purpose of this work is to develop a sensitive, selective, and stability indicating reverse phase HPLC assay for the quality control analysis and stability testing of mexiletine hydrochloride dosage forms. The method was developed to quantify the drug for various formulations. Analysis was carried out on a 4 mm × 150 mm C-18 microsorb column, using a 50:50 methanol:0.053 M sodium acetate buffer. The pH of the mobile phase was adjusted to 4.8. The flow rate was set at 1 mL/min and the analysis was carried out at 254 nm. The internal standard used in the analysis was thiamine hydrochloride. The drug eluted at about 8 min, while the internal standard eluted at about 3 min. The stability of the assay was studied by subjecting the drug to extreme pH conditions. The limit of quantification (LOQ) and limit of detection (LOD) were found to be 0.06 µg and 0.02 µg, respectively. The reproducibility of the method was tested by carrying out multiple injections on the same day, as well as, on five consecutive days. The coefficient of variation for the intra-day and inter-day studies was found to be 0.81% and 1.47%, respectively. [ABSTRACT FROM AUTHOR]
Copyright of Journal of Liquid Chromatography & Related Technologies is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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DbLabel: Engineering Source
An: 9438567
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  Label: Title
  Group: Ti
  Data: A Modified Reverse-Phase HPLC Method for the Analysis of Mexiletine Hydrochloride.
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  Data: <searchLink fieldCode="AR" term="%22Kaushik%2C+Sarita%22">Kaushik, Sarita</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Alexander%2C+K%2ES%2E%22">Alexander, K.S.</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> kalexan@utnet.utoledo.edu</i>
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  Data: <searchLink fieldCode="JN" term="%22Journal+of+Liquid+Chromatography+%26+Related+Technologies%22">Journal of Liquid Chromatography & Related Technologies</searchLink>. Apr2003, Vol. 26 Issue 8, p1287-1296. 10p. 3 Charts.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Mexiletine%22">Mexiletine</searchLink><br /><searchLink fieldCode="DE" term="%22Liquid+chromatography%22">Liquid chromatography</searchLink><br /><searchLink fieldCode="DE" term="%22Vitamin+B1%22">Vitamin B1</searchLink><br /><searchLink fieldCode="DE" term="%22Methanol%22">Methanol</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Mexiletine hydrochloride is an orally active class I antiarrythmic agent. The purpose of this work is to develop a sensitive, selective, and stability indicating reverse phase HPLC assay for the quality control analysis and stability testing of mexiletine hydrochloride dosage forms. The method was developed to quantify the drug for various formulations. Analysis was carried out on a 4 mm × 150 mm C-18 microsorb column, using a 50:50 methanol:0.053 M sodium acetate buffer. The pH of the mobile phase was adjusted to 4.8. The flow rate was set at 1 mL/min and the analysis was carried out at 254 nm. The internal standard used in the analysis was thiamine hydrochloride. The drug eluted at about 8 min, while the internal standard eluted at about 3 min. The stability of the assay was studied by subjecting the drug to extreme pH conditions. The limit of quantification (LOQ) and limit of detection (LOD) were found to be 0.06 µg and 0.02 µg, respectively. The reproducibility of the method was tested by carrying out multiple injections on the same day, as well as, on five consecutive days. The coefficient of variation for the intra-day and inter-day studies was found to be 0.81% and 1.47%, respectively. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Journal of Liquid Chromatography & Related Technologies is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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    Identifiers:
      – Type: doi
        Value: 10.1081/JLC-120020111
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 10
        StartPage: 1287
    Subjects:
      – SubjectFull: Mexiletine
        Type: general
      – SubjectFull: Liquid chromatography
        Type: general
      – SubjectFull: Vitamin B1
        Type: general
      – SubjectFull: Methanol
        Type: general
    Titles:
      – TitleFull: A Modified Reverse-Phase HPLC Method for the Analysis of Mexiletine Hydrochloride.
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            NameFull: Kaushik, Sarita
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            NameFull: Alexander, K.S.
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            – D: 15
              M: 04
              Text: Apr2003
              Type: published
              Y: 2003
          Identifiers:
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              Value: 10826076
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              Value: 26
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              Value: 8
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            – TitleFull: Journal of Liquid Chromatography & Related Technologies
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