Original Articles: 2016 Vol: 8 Issue: 2
Development and validation of analysis method for tablet ibuprofen by thin layer chromatography-densitometry
Abstract
A simple, selective and accurate thin layer chromatography (TLC)-densitometry method has been developed and validated for analysis of ibuprofen in pharmaceutical preparations. Ibuprofen assay was performed by TLCdensitometry using silica gel 60 F254 plates as the stationary phase and a mixture of chloroform: methanol (10: 1) as the best mobile phase. Standard solution of ibuprofen in the range of 2-10 mg/mL resulted in a regression equation y = 14293.868 + 4201.72x with r = 0.9973. Ibuprofen detection limit was 0.88 mg/mL and the limit of quantification of ibuprofen was 2.70 mg/mL. Accuracy in generic ibuprofen tablets of PT Indo Farma and ibuprofen tablets under the trade name Proris® of PT Pharos had percent recovery range which meets 80-110 %. Precision intraday and interday had good repeatability as RSD ≤ 2 %. The analysis showed levels of ibuprofen on a generic tablet of 97.56 % ± 0.59 % and ibuprofen tablets under the trade name Proris® of 101.76 % ± 2.02 %. The levels ibuprofen obtained have suitably qualified Indonesian Pharmacopoeia edition V i.e. 90-110 %.