Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Validated High Performance Liquid Chromatography Method for Analysis of Cefadroxil Monohydrate in Human Plasma

Najia Rahim¹ , Syed Baqir Shyum Naqvi², Mehtab Alam³, Erum Iqbal³, Rehana Bibi²

¹Dow College of Pharmacy, Dow University of Health Sciences; ²Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi; ³Institute of Pharmaceutical and Environmental Research, Dow University of Health Sciences, Karachi, Pakistan.

For correspondence:- Najia Rahim Email: najia.rahim@duhs.edu.pk Tel:+923002117194

Received: 3 September 2013 Accepted: 19 March 2014 Published: 26 June 2014

Citation: Rahim N, Naqvi SB, Alam M, Iqbal E, Bibi R. Validated High Performance Liquid Chromatography Method for Analysis of Cefadroxil Monohydrate in Human Plasma. Trop J Pharm Res 2014; 13(6):975-979 doi: 10.4314/tjpr.v13i6.22

© 2014 The authors.
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Abstract

Purpose: To develop a simple, rapid and sensitive high performance liquid chromatography (HPLC) method for the determination of cefadroxil monohydrate in human plasma.

Methods: Schimadzu HPLC with LC solution software was used with Waters Spherisorb, C18 (5 µm, 150mm × 4.5mm) column. The mobile phase was sodium dihydrogen phosphate buffer pH 4.0 and methanol in a ratio of 96:4. Flow rate was 1.5 ml/min and injection volume was 100 µl. Peak response was detected at 260 nm.

Results: System suitability results revealed that the coefficient of variation (CV) for retention time, peak response, tailing factor and resolution of six replicate injections was < 3 %. The method was selective to determine cefadroxil in plasma because there was no peak interference of plasma with cefadroxil at its retention time (7.792 min). Linearity was in the range of 0.5 - 30 µg/ml with slope and intercept of 41694.53 and 22614.87, respectively (R² = 0.9953). Limit of detection (LOD) and lower limit of quantification (LLOQ) of the method were 0.03 and 0.06 µg/ml, respectively. Absolute recovery of cefadroxil from plasma was in the range 71 - 90.4 %, while inter-day and intra-day analysis showed satisfactory precision and accuracy; thus, the method was reproducible with the range of CV, i.e., 0.35 - 4.01 and 1.88 - 7.9 % for interday and intraday precision, respectively.

Conclusion: The developed method being simple, rapid, reproducible can be suitably employed in pharmacokinetic and bioequivalence studies of cefadroxil monohydrate.

Keywords: Validation, Cefadroxil monohydrate, Human plasma, Pharmacokinetics Bioequivalence