Bioanalytical Validatýon and Accurate RP-HPLC Method Development of Triamcinolone: Application to Bioequývalence Studies
Selvadurai Muralidharan1, Vijayan Venugopal2, Jayaraja Kumar2, Subramani Parasuraman31Pharmaceuticalchemistry Unit, Faculty Of Pharmacy, Aýmst University, Malaysia2Pharmaceuticaltechnology Unit,faculty Of Pharmacy, Aýmst University, Malaysia
3Pharmacology Unit,faculty Of Pharmacy, Aýmst University, Malaysia
The present simple and sensitive method has been developed for the purpose of bioanalytical study of triamcinolone. The chromatography condition was optimized using a mobile phase 0.5% Tri-Ethyl Amine (TEA) (), pH- 3.48 and acetonitrile in the ratio of 50: 50 at flow rate 1ml/min. and the stationary phase was used as thermo C18 column. The plasma extraction method, protein precipitation technique was achieved 79.5% using 5% of trichloro acetic acid. The drug was eluted at 5.1 min. and no plasma endogenous materials were observed in the retention time. The limit of quantitation (LOQ) of the present method is 100ng/mL and linearity was in the range of 0.5-15.0 μg/mL. The range of drug r2 had shown 0.999. The present successful development and validated method of triamcinolone is shown good accuracy, precision and linearity.
Keywords: Drug free human plasma, HPLC, Optimization, Triamcinolone, ValidationBioanalytical Validatýon and Accurate RP-HPLC Method Development of Triamcinolone: Application to Bioequývalence Studies
Selvadurai Muralidharan1, Vijayan Venugopal2, Jayaraja Kumar2, Subramani Parasuraman31Pharmaceuticalchemistry Unit, Faculty Of Pharmacy, Aýmst University, Malaysia2Pharmaceuticaltechnology Unit,faculty Of Pharmacy, Aýmst University, Malaysia
3Pharmacology Unit,faculty Of Pharmacy, Aýmst University, Malaysia
The present simple and sensitive method has been developed for the purpose of bioanalytical study of triamcinolone. The chromatography condition was optimized using a mobile phase 0.5% Tri-Ethyl Amine (TEA) (), pH- 3.48 and acetonitrile in the ratio of 50: 50 at flow rate 1ml/min. and the stationary phase was used as thermo C18 column. The plasma extraction method, protein precipitation technique was achieved 79.5% using 5% of trichloro acetic acid. The drug was eluted at 5.1 min. and no plasma endogenous materials were observed in the retention time. The limit of quantitation (LOQ) of the present method is 100ng/mL and linearity was in the range of 0.5-15.0 μg/mL. The range of drug r2 had shown 0.999. The present successful development and validated method of triamcinolone is shown good accuracy, precision and linearity.
Anahtar Kelimeler: Drug free human plasma, HPLC, Optimization, Triamcinolone, ValidationCorresponding Author: Selvadurai Muralidharan, Malaysia
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