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...

Full description

Bibliographic Details
Main Authors: Mutalabisin, Muhammad Fathiy, Chatterjee, Bappaditya
Format: Conference or Workshop Item
Language:English
English
English
Published: 2018
Subjects:
Online Access: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
id iium-68357
recordtype eprints
spelling 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)
repository_type Digital Repository
institution_category Local University
institution International Islamic University Malaysia
building IIUM Repository
collection Online Access
language English
English
English
topic RS192 Materia Medica-Pharmaceutical Technology
spellingShingle 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
last_indexed 2023-09-18T21:37:01Z
_version_ 1777412888576655360