Abstract
Purpose: To develop and validate a new low-cost high performance liquid chromatography (HPLC) method for simultaneous analysis of theophylline (TH), guaifenesin (GF) and diphenhydramine hydrochloride (DH) in elixir dosage form.Methods: Chromatographic conditions were an isocratic elution with C18-Kromasil® column (250 x 4.6 mm, 5 μm), methanol-water (1:1, v/v, pH 3,0) as mobile phase, flow rate 1.0 ml/min and UV detector at λ 218 nm. The method was validated for selectivity, linearity, LOD-LOQ, precision, and accuracy.Results: Retention time of TH, GF and DH was 3.3, 5.3 and 9.1 min, respectively. The method showed good selectivity, calibration curves were linear over the concentration range of 1.000 – 10.002 μg/mL, 0.801 – 8.008 μg/mL, and 0.251 – 2.514 μg/mL (r2 > 0.999). LOD was 0.1093, 0.16520, and 0.0706 μg/mL, while LOQ was 0.3645, 0.5506, and 0.2354 μg/mL for TH, GF and DH, respectively. Recovery accuracy was 99.77 - 101.10, 100.50 - 101.95 and 99.20 - 100.13 % for TH, GF and DH, respectively; precision (RSD) was < 2.0.Conclusion: The proposed method is highly selective, sensitive, precise, and accurate, and would suitable for the simultaneous analysis of TH, GF, and DH in elixir dosage form. Since methanol is cheaper than acetonitrile, the application of the method may reduce the cost of analysis.Keywords: Simultaneous analysis, Theophylline, Guaifenesin, Diphenhydramine hydrochloride, Elixir
Highlights
Theophylline (TH), guaifenesin (GF) and diphenhydramine hydrochloride (DH) (Figure 1) is a combination of the active ingredients contained in elixir dosage form
The reversed phase high performance liquid chromatographic (HPLC) method has been widely used for the assay of one or two active ingredients simultaneously in dosages form containing TH, GF and or DH, or other active ingredients [3,4,5,6,7,8]
The HPLC methods have been used for the simultaneous analysis of these three active ingredients in a mixture with some other active substances or excipients using acetonitrile-phosphate buffer pH 3.2 as mobile phase [9,10]
Summary
Theophylline (TH), guaifenesin (GF) and diphenhydramine hydrochloride (DH) (Figure 1) is a combination of the active ingredients contained in elixir dosage form. This combination is used for a treatment of bronchial asthma and asthmatic bronchitis conditions [1,2]. The HPLC methods have been used for the simultaneous analysis of these three active ingredients in a mixture with some other active substances or excipients using acetonitrile-phosphate buffer pH 3.2 as mobile phase [9,10]. The objective of the present study was the development and validation of a new reversed-phase HPLC method for simultaneous analysis of TH, GF and DH in elixir dosage form, using a mixture of methanol-water as mobile phase
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