Validation and Quantification of Theophylline and Salbutamol using Ion Pair Liquid Chromatography
Abstract: Salbutamol and theophylline
are administered in combination orally to provide the sinergistic effect of
drugs. The aim of this study is to develop and to validate ion pair liquid
chromatography to determine both drugs in pharmaceutical dosage form, especialy
in syrup dosage form. Separation of drugs was performed with Spherisorb C-18
column (250 x 4.6 mm; 10 um). The mobile phase used is the mixture of acetic
acid 1% : methanol (60 : 40 v/v) which contain 3.5 mM
sodium-1-octanesulphonate, as ion pairing reagent. The mobile phase was
delivered isocratically with flow rate of 1 mL/min. UV detection was set at
wavelength of 277 nm. The developed method was validated in terms of linearity,
precision, accuracy, selectivity, and sensitivity. The precision of the method
was evaluated using repeatability assay having relative standard deviation
(RSD) values of 0.41–0.70 % for theophylline and 0.08 – 0.24 % for salbutamol.
The recovery percentages are in the range of 98.28–101.02% (theophylline) and
100.71–101.60% for salbutamol. The developed method meets the validation
requirement for analysis of salbutamol and theophylline simultaneously in syrup
dosage form. Furthermore, the method also provides acceptable result for syrup
and tablet dosage forms containing Salbutamol and theophylline only, and tablet
containing the combination of Salbutamol and theophylline.
Keywords: teophyllin,
salbutamol, HPLC, sodium-1-octanesulphonate, validation
Author: Shanti Laksmi Sophi,
Sudibyo Martono, Abdul Rohman
Journal Code: jpfarmasigg160044
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