Determination of Pregabalin in Bulk Drug and Pharmaceutical Formulations using Validated Stability-indicating Spectrophotometric Methods

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Eman Wafik Eskander Farag
Eman Wafik Eskander Farag
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Maha Farouk Abdel Ghany
Maha Farouk Abdel Ghany
α Amoun pharmaceutical company

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Determination of Pregabalin in Bulk Drug and Pharmaceutical Formulations using Validated Stability-indicating Spectrophotometric Methods

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Abstract

The present study describes the development and subsequent validation of stabilityindicating, accurate, reliable, and sensitive spectro-photometric methods for the determination of Pregabalin in presence of its degradation products, including Dual wavelength and Ratio derivative after derivatization with vanillin reagent. With the Dual wavelength technique, Pregabalin could be determined in the range of 40-160 μg/mL at 390nm and 395.8nm. With the Ratio derivative technique, it could be determined in the above ranges at 401.6nm. All the methods were validated according to the International Conference on Harmonization guidelines and successfully applied to determine Pregabalin in pure form, laboratory-prepared mixtures, and pharmaceutical formulation. The obtained results were statistically compared with reported methods of analysis and there were no significant differences with respect to accuracy and precision of the adopted techniques.

References

16 Cites in Article
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Funding

No external funding was declared for this work.

Conflict of Interest

The authors declare no conflict of interest.

Ethical Approval

No ethics committee approval was required for this article type.

Data Availability

Not applicable for this article.

How to Cite This Article

Eman Wafik Eskander Farag. 2018. \u201cDetermination of Pregabalin in Bulk Drug and Pharmaceutical Formulations using Validated Stability-indicating Spectrophotometric Methods\u201d. Global Journal of Science Frontier Research - B: Chemistry GJSFR-B Volume 18 (GJSFR Volume 18 Issue B3): .

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Issue Cover
GJSFR Volume 18 Issue B3
Pg. 31- 37
Journal Specifications

Crossref Journal DOI 10.17406/GJSFR

Print ISSN 0975-5896

e-ISSN 2249-4626

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GJSFR-B Classification: FOR Code: 111599
Version of record

v1.2

Issue date

September 5, 2018

Language
en
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The present study describes the development and subsequent validation of stabilityindicating, accurate, reliable, and sensitive spectro-photometric methods for the determination of Pregabalin in presence of its degradation products, including Dual wavelength and Ratio derivative after derivatization with vanillin reagent. With the Dual wavelength technique, Pregabalin could be determined in the range of 40-160 μg/mL at 390nm and 395.8nm. With the Ratio derivative technique, it could be determined in the above ranges at 401.6nm. All the methods were validated according to the International Conference on Harmonization guidelines and successfully applied to determine Pregabalin in pure form, laboratory-prepared mixtures, and pharmaceutical formulation. The obtained results were statistically compared with reported methods of analysis and there were no significant differences with respect to accuracy and precision of the adopted techniques.

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Determination of Pregabalin in Bulk Drug and Pharmaceutical Formulations using Validated Stability-indicating Spectrophotometric Methods

Eman Wafik Eskander Farag
Eman Wafik Eskander Farag Amoun pharmaceutical company
Maha Farouk Abdel Ghany
Maha Farouk Abdel Ghany

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