Asian Journal of Research in Pharmaceutical Sciences

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Development and Validation of RP-HPLC Method for Estimation of Cefuroxime Axetil in Spiked Human Plasma with UV Detection


Affiliations
1 Department of Quality Assurance Techniques, MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik 422 003, Maharashtra State, India
2 Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik 422 003, Maharashtra State, India
     

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A simple, rapid and accurate RP-HPLC method was developed and validated for the estimation of cefuroxime axetil in spiked human plasma using liquid-liquid extraction. Sufficient recovery was obtained when drug and internal standard (Guaifensin) were extracted using ethyl acetate with 1% formic acid. The chromatographic separation was performed on C18 (250 × 4.6 mm, 5 μm) column with mobile phase consisting of Potassium dihydrogenortho phosphate: methanol (60:40% v/v). The flow rate was kept constant at 1 mL/min and detection was carried out at 276 nm. The calibration curve was found linear in the range of 1000-32000 ng/mL To minimize the heteroscedasticity, weighted calibration models were used with different weighing factors. The method was validated as per the US-FDA guidelines.

Keywords

Cefuroxime Axetil, Weighted Regression, RP-HPLC, Spiked Human Plasma, Bioanalytical Method Validation.
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  • Indian Pharmacopoeia. Volume II, Published by Indian Pharmacopoeial Commission, Ministry of Health and Family Welfare:2014:1325

  • Nafiz, O. C., Altiokka, H. Y., Hassan, Y and Aboul-Enein. Determination of cefuroxime axetil in tablets and biological fluids using liquid chromatography and flow injection analysis. Analytica Chimica Acta, (576) 2006: 246-252.

  • Dean, J. R. Extraction techniques in analytical sciences. John Wiley and Sons, (8) 2009

  • Dolan, J.W. Calibration Curves, Part V: Curve Weighting. LCGC North America.;27(7)2009: 6

  • U. S. Department of Health and Human Services F, and Drug Administration. Guidance for Industry, Bioanalytical Method Validation. U S Department of Health and Human Services, FDA:10: 2001


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  • Development and Validation of RP-HPLC Method for Estimation of Cefuroxime Axetil in Spiked Human Plasma with UV Detection

Abstract Views: 219  |  PDF Views: 0

Authors

Bhalerao Atharva
Department of Quality Assurance Techniques, MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik 422 003, Maharashtra State, India
Gade Vilas
Department of Quality Assurance Techniques, MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik 422 003, Maharashtra State, India
Sonawane Sandeep
Department of Quality Assurance Techniques, MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik 422 003, Maharashtra State, India
Chhajed Santosh
Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik 422 003, Maharashtra State, India
Kshirsagar Sanjay
Department of Quality Assurance Techniques, MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik 422 003, Maharashtra State, India

Abstract


A simple, rapid and accurate RP-HPLC method was developed and validated for the estimation of cefuroxime axetil in spiked human plasma using liquid-liquid extraction. Sufficient recovery was obtained when drug and internal standard (Guaifensin) were extracted using ethyl acetate with 1% formic acid. The chromatographic separation was performed on C18 (250 × 4.6 mm, 5 μm) column with mobile phase consisting of Potassium dihydrogenortho phosphate: methanol (60:40% v/v). The flow rate was kept constant at 1 mL/min and detection was carried out at 276 nm. The calibration curve was found linear in the range of 1000-32000 ng/mL To minimize the heteroscedasticity, weighted calibration models were used with different weighing factors. The method was validated as per the US-FDA guidelines.

Keywords


Cefuroxime Axetil, Weighted Regression, RP-HPLC, Spiked Human Plasma, Bioanalytical Method Validation.

References