Development and Validation of RP-HPLC Method For Simultaneous Determination of Guaifenesin Impurities in Multi  Drug Combinations

Development and Validation of RP-HPLC Method For Simultaneous Determination of Guaifenesin Impurities in Multi Drug Combinations

Tigran K. Davtyan

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Levon A. Melikyan

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Rosa S. Grigoryan

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α Analytical Laboratory Branch, Scientific Center of Drug and Medical Technology Expertise JSC, Ministry of Health of Armenia,

Development and Validation of RP-HPLC Method For Simultaneous Determination of Guaifenesin Impurities in Multi Drug Combinations

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Abstract

A High Performance Liquid Chromatographic method was developed and validated for quantitative determination of Guaifenesin impurities including 2-(2-methoxyphenoxy)propane-1,3-diol (β-isomer) and 2methoxyphenol (guaiacol) in different multi drug components pharmaceutical dosage forms, containing guaifenesin, ambroxol hydrochloride and salbutamol sulfate . The different analytical performance parameters such as linearity, precision, accuracy, limit of detection (LOD), limit of Quantification (LOQ) were determined according to International Conference on Harmonization (ICH) Q2B guidelines. The chromatographic separation was achieved on EC NUCLEODUR-100-3C18 (250×4,6 mm, 5μm packing) column using gradient elution of Solvent A (0.1 M ammonium acetate buffer of pH 6.8) and solvent B (acetonitrile : methanol (80:20)) The Ultra Violet spectrophotometric determination was performed at 275 nm. The Linearity of the calibration curves for the analytes in the desired concentration range is good (r2 = 0.999) by High Performance Liquid Chromatography. The LOQ were 1 and 0.1 μg/ml respectively for guaifenesin β-isomer and guaiacol. The average percentage recovery of guaifenesin impurities was found to be within 98.6 -101.2% of range. The developed method can be successfully used for identification and quantification of guaifenesin impurities β-isomer and guaiacol in the presence of guaifenesin, ambroxol hydrochloride and salbutamol sulfate in multi drug components pharmaceutical formulations.

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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

Tigran K. Davtyan. 2014. \u201cDevelopment and Validation of RP-HPLC Method For Simultaneous Determination of Guaifenesin Impurities in Multi Drug Combinations\u201d. Global Journal of Medical Research - B: Pharma, Drug Discovery, Toxicology & Medicine GJMR-B Volume 14 (GJMR Volume 14 Issue B2): .

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GJMR Volume 14 Issue B2
Pg. 27- 34

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Journal Specifications

Crossref Journal DOI 10.17406/gjmra

Print ISSN 0975-5888

e-ISSN 2249-4618

Keywords

2-(2-methoxyphenoxy)-propane-1 3-diol (β-isomer) and 2- methoxyphenol (guaiacol)guaifenesin impurities RP-HPLC Validation

Submission ReceivedDecember 15, 2013
Peer Review Double Blind
Handling Editor
Accepted January 3, 2014
Published January 15, 2014

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v1.2

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June 3, 2014

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Article Matrices

Total Score: 103

Country: Armenia

Subject: Global Journal of Medical Research - B: Pharma, Drug Discovery, Toxicology & Medicine

Authors: Levon A. Melikyan, Rosa S. Grigoryan, Tigran K. Davtyan (PhD/Dr. count: 0)

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