Abstract
A novel, simple, accurate and precise RP-HPLC method for simultaneous determination of levosalbutamol sulfate and theophylline has been developed and validated. Separation was achieved on a Phenomenex; C18 column (250 mm × 4.6 mm i.d., 5 µm) using methanol: 10 mM TBAHS(tetrabutyl ammonium hydrogen sulfate) (50:50, v/v) as mobile phase at flow rate of 1.0 mL.min-1. The UV detection wavelength was 274 nm. The linearity is obeyed over a concentration range of 0.5-150 µg.mL-1 with correlation coefficient of 0.999 for both the drugs. The proposed method was validated by determining accuracy, precision, stability and system suitability parameters. The method was found to be robust. Specificity of the method was determined by subjecting the drugs to various stress conditions like acid, alkali, oxidation, thermal and photolytic degradation. The method was used successfully for the simultaneous determination of levosalbutamol sulfate and theophylline in syrup dosage form.
Highlights
Levosalbutamol sulfate, (R)-α-[(tertbutylamino)-4-hydroxy-m-xylene-αα-diol sulfate(2:1) is a bronchodilator indicated for management of asthma
Literature review shows that no stability-indicating RP-HPLC methods are present so far for simultaneous estimation of levosalbutamol sulfate and theophylline in combined syrup dosage form using methanol: 10 mM Tetra Butyl Ammonium Hydrogen Sulfate (TBAHS) as the mobile phase
Method development process was carried out by examining conditions like flow rate (0.8 mL.min-1, 1.0 mL.min-1 and 1.2 mL.min-1), mobile phase compositions like acetonitrile:water, acetonitrile:buffer, methanol:water, methanol: 10 mM TBAHS and ratios (50:50, 60:40 and 45:60, v/v) were used. Both the drugs levosalbutamol sulfate and theophylline were found showing a significant UV absorbance at 274 nm in methanol: 10 mM TBAHS (50:50, v/v), so this wavelength was chosen for UV detection
Summary
Levosalbutamol sulfate (levalbuterol), (R)-α-[(tertbutylamino)-4-hydroxy-m-xylene-αα-diol sulfate(2:1) is a bronchodilator indicated for management of asthma. It is preferred over racemic salbutamol sulfate for increased efficacy and safety after use (Berger, 2003). Theophylline, 3,7-dihydro-1,3-dimethyl purine-2,6(1H)-dione is a xanthine derivative used for management of asthma and. Literature review shows that no stability-indicating RP-HPLC methods are present so far for simultaneous estimation of levosalbutamol sulfate and theophylline in combined syrup dosage form using methanol: 10 mM TBAHS (tetra butyl ammonium hydrogen sulfate) as the mobile phase. Stability-indicating RP-HPLC method for simultaneous determination of levosalbutamol sulfate and theophylline in syrup dosage form. The method was validated according to requirements of ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2005) guideline
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