ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TRICLOSAN IN DENTAL FORMULATIONSAbstract
The present study is a simple rapid, sensitive, selective and reproducible RP-HPLC method has been developed for the estimation of Triclosan in dental formulations. In present work a simple, sensitive and specific method (RP-HPLC assay, stability indicating RP-HPLC) has been developed by using a phenomenex, BDS C18, column having 5 µm particle size and 150 mm × 4.6 mm in length and gradient mode, with mobile phase containing acetic acid buffer (pH 2.5, adjusted with formic acid) and acetonitrile in the ratio of 30:70. The flow rate was 1.2 mL/min and effluents were monitored by PDA detector at 281nm. Injection volume was 20 µL. The method is linear (1-50 µg/mL). The regression equation was y = 7311x-2307 (r2 = 0.997). The method was validated for linearity, precision, accuracy, ruggedness, and forced degradation studies were performed. Estimation of triclosan was done in 3 dental formulations. Recoveries from formulations were between 98% and 102%. Limit of detection and limit of quantification was 0.101433 and 0.3333µg/mL, respectively. All the validation parameters are within the acceptance range.
P. Mahitha, B. M. Gurupadayya * and R. S. Chandan
Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS University, Mysore, India.
07 March 2014
18 April 2014
01 July 2014
01 September 2014