SIMULTANEOUS DETERMINATION OF GUAIFENESIN AND EPHEDRINE HCl BINARY MIXTURE IN SYRUP DOSAGE FORMS AND HUMAN PLASMA BY USING RP-HPLC-DAD

Abstract

A new and simple quantitative analysis method for the determination of Guaifenesin (G) and Ephedrine HCl (E) binary mixtures was developed and validated. Phosphate buffer–methanol combination (60:40, v/v) was chosen as an isocratic mobile phase and adjusted to pH 3 for this liquid chromatographic method which was developed for the simultaneous analysis of G and E combination. The method was observed in concentration ranges of 30–100 µg mL⁻¹ (G) and 15–50 µg mL⁻¹(E). The total run time for detections performed at 212 nm was less than 10 min.

The reverse phase-high performance liquid chromotography (RP-HPLC) method developed in this study was successfully applied to pharmaceutical preparations in syrup dosage form and human plasma samples (in vitro) without liquid–liquid extraction. And the statistical comparison of this method was performed both in pharmaceutical preparations and human plasma samples.

Keywords:

• binary mixtures
• ephedrine HCl
• Guaifenesin (Glyceryl Guaiacolate)
• human plasma samples
• RP-HPLC method
• syrup dosage forms

Notes

RSD: relative standard deviation (100 SD/mean), LOQ (S/N = 8), LOD (S/N = 3).

X: mean value, SD: standard deviation, RSD: relative standard deviation (100 SD/mean).

X: mean value, SD: standard deviation, RSD: relative standard deviation (100 SD/mean).

Recovery: (found/added)100, Accuracy (relative error): (found − added/added)100.

Recovery: (found/added)100, Accuracy (relative error): (found − added/added)100.

X: mean recovery, SD: standard deviation, RSD: relative standard deviation (100 SD/mean).

Recovery: (found/added)100, Accuracy (relative error): (found − added/added)100.

X: mean recovery, SD: standard deviation, RSD: relative standard deviation (100 SD/mean).

Recovery: (found/added)100, SD: standard deviation, RSD: relative standard deviation (100 SD/mean).

Standard error: standard deviation/√n, t_C: calculated t-value, t_T: tabulated t-value.

Standard error: standard deviation/√n, F_C: calculated F-value, F_T: tabulated F-value.