Quantitation of pregabalin by pre-column derivatization HPLC with UV detection
Introduction: Pregabalin, a drug used to treat neuropathic pain, cannot be detected in its original form by simple high performance liquid chromatography (HPLC) with UV or fluorescence detector due to absence of chromophore group. Objective: To develop and validate a HPLC method with UV detection...
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iium-683572018-12-27T07:47:55Z http://irep.iium.edu.my/68357/ Quantitation of pregabalin by pre-column derivatization HPLC with UV detection Mutalabisin, Muhammad Fathiy Chatterjee, Bappaditya RS192 Materia Medica-Pharmaceutical Technology Introduction: Pregabalin, a drug used to treat neuropathic pain, cannot be detected in its original form by simple high performance liquid chromatography (HPLC) with UV or fluorescence detector due to absence of chromophore group. Objective: To develop and validate a HPLC method with UV detection by pre-column derivatization reaction. Method: Pregabalin, as in the raw form, was derivatized with ninhydrin to form a chromophoric complex. The reaction steps are mixing pregabalin solution in phosphate buffer (pH 7.4) with ninhydrin followed by heating at 70-75 ⁰C for 20 minutes. The HPLC method developed consists of a C18 separation column (150 mm X 4.6 mm internal diameter), mobile phase (buffer pH 5:acetonitrile, 70:30), 1 ml/min flow rate, 569 nm wavelength of detection and 10 min run time. The method was validated using specificity, linearity, range, precision-accuracy parameters. Results: The derivatization reaction was reproducible and it was observed that ninhydrin amount is an important factor. The method was shown to be specific for determination of the complex. It was linear within concentration range 600 µg/ml to 100 µg/ml with correlation coefficient (R2 ) value >0.99. Accuracy value for 3 levels of quality control sample (500, 300 and 100µg/ml) were more than 90%. Precision of the method was established by less than 2% value of relative standard deviation (RSD) between accuracies of each level of quality control samples. Conclusion: The developed method is capable to quantify pregabalin in bulk formulation. However, it would be applied to quantify the drug in formulation 2018 Conference or Workshop Item NonPeerReviewed application/pdf en http://irep.iium.edu.my/68357/1/PRCP18%20%28Fathiy%29.pdf application/pdf en http://irep.iium.edu.my/68357/7/4IPRC.pdf application/pdf en http://irep.iium.edu.my/68357/12/Poster%20iPRC%202018.pdf Mutalabisin, Muhammad Fathiy and Chatterjee, Bappaditya (2018) Quantitation of pregabalin by pre-column derivatization HPLC with UV detection. In: 4th International Pharmaceutical Research Conference 2018, 25th-26th August 2018, Cyberjaya, Malaysia. (Unpublished) |
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RS192 Materia Medica-Pharmaceutical Technology Mutalabisin, Muhammad Fathiy Chatterjee, Bappaditya Quantitation of pregabalin by pre-column derivatization HPLC with UV detection |
description |
Introduction: Pregabalin, a drug used to treat neuropathic pain, cannot be detected in its original form by simple high performance liquid chromatography (HPLC) with UV or fluorescence detector due to absence of chromophore group.
Objective: To develop and validate a HPLC method with UV
detection by pre-column derivatization reaction.
Method: Pregabalin, as in the raw form, was derivatized with ninhydrin to form a chromophoric complex. The reaction steps are mixing pregabalin solution in phosphate buffer (pH 7.4) with ninhydrin followed by heating at 70-75 ⁰C for 20 minutes. The HPLC method developed consists of a C18 separation column (150 mm X 4.6 mm internal diameter), mobile phase (buffer pH 5:acetonitrile, 70:30), 1 ml/min flow rate, 569 nm wavelength of detection and 10 min run time. The method was validated using specificity, linearity, range, precision-accuracy parameters.
Results: The derivatization reaction was reproducible and it was observed that ninhydrin amount is an important factor. The method was shown to be specific for determination of the complex. It was linear within concentration range 600 µg/ml to 100 µg/ml with correlation coefficient (R2 ) value >0.99. Accuracy value for 3 levels of quality control sample (500, 300 and 100µg/ml) were more than 90%. Precision of the method was established by less than 2% value of relative standard deviation (RSD) between accuracies of each level of quality control samples.
Conclusion: The developed method is capable to quantify
pregabalin in bulk formulation. However, it would be applied to quantify the drug in formulation |
format |
Conference or Workshop Item |
author |
Mutalabisin, Muhammad Fathiy Chatterjee, Bappaditya |
author_facet |
Mutalabisin, Muhammad Fathiy Chatterjee, Bappaditya |
author_sort |
Mutalabisin, Muhammad Fathiy |
title |
Quantitation of pregabalin by pre-column derivatization HPLC with UV detection |
title_short |
Quantitation of pregabalin by pre-column derivatization HPLC with UV detection |
title_full |
Quantitation of pregabalin by pre-column derivatization HPLC with UV detection |
title_fullStr |
Quantitation of pregabalin by pre-column derivatization HPLC with UV detection |
title_full_unstemmed |
Quantitation of pregabalin by pre-column derivatization HPLC with UV detection |
title_sort |
quantitation of pregabalin by pre-column derivatization hplc with uv detection |
publishDate |
2018 |
url |
http://irep.iium.edu.my/68357/ http://irep.iium.edu.my/68357/1/PRCP18%20%28Fathiy%29.pdf http://irep.iium.edu.my/68357/7/4IPRC.pdf http://irep.iium.edu.my/68357/12/Poster%20iPRC%202018.pdf |
first_indexed |
2023-09-18T21:37:01Z |
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2023-09-18T21:37:01Z |
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