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

Eman Wafik Eskander Farag; Maha Farouk Abdel Ghany

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

Eman Wafik Eskander Farag * §

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Maha Farouk Abdel Ghany §

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§ Amoun pharmaceutical company

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, Maha Farouk Abdel Ghany. 2018. "Determination of Pregabalin in Bulk Drug and Pharmaceutical Formulations using Validated Stability-indicating Spectrophotometric Methods". Global Journal of Science Frontier Research - B: Chemistry GJSFR-B Volume 18 (GJSFR Volume 18 Issue B3).

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GJSFR Volume 18 Issue B3

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Journal Specifications

Crossref Journal DOI 10.17406/GJSFR

Print ISSN 0975-5896

e-ISSN 2249-4626

Keywords

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Classification

GJSFR-B Classification FOR Code: 111599

Submission ReceivedJuly 27, 2018
Peer Review Double Blind
Handling Editor
Accepted August 18, 2018
Published August 28, 2018

Version of record

v1.2

Issue date

September 5, 2018

Language

English

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Article Matrices

Total Score: 102

Country: Egypt

Subject: Global Journal of Science Frontier Research - B: Chemistry

Authors: Eman Wafik Eskander Farag, Maha Farouk Abdel Ghany (PhD/Dr. count: 0)

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Publish Date: 2018 08, Tue

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