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Optimasi dan Validasi Metode Penetapan Kadar Testosteron Undekanoat dalam Sediaan Mikroemulsi Secara kromatograpfi Cair Kinerja Tiggi (KCKT) (Optimization and Velidation of Determination Mthode Methods of Testosteron Undecanoate Concentration in Microemulsion dosage farm by high performance Liquid Chromatography (HPLC)
Testosterone undecarnoate was one of the esters of testoterone. Microemulsion was selected as the formula for testoterone undecanote based on the clinical considerations and their physico-chemical properties. This study aims at finding catch optimum conditions for the analysis of testosterone undercanoate in microemulsion by high performance Liquid Chromatography (HPLC) and a vaidation is also included. Conditions of chromatography were Supelconsil colum LC-18 (25 cm x 4,6 mm; 5µm) reverse phase, mobile methanol-acetonitrile (90;10 v/v), flow rate 2 mL/mim, injection volume 5µL, and analyzed at were length 245 nm with ultraviolet-visible detector. In the range of concentration 100-600 µg/mL has correlation coefficent to the calibration curves of (r) 0,99983, with limit of detection is 12,59 µg/mL and limit of quantitation is µg/mL 38,16, accuracy (5 diff) has renged -0,03%, coefficient variation of predision ranged between 0,52-0,89% and the recovery value has a range of 99,98-101,03%. The validation result has met the requirements set and can be applied for the determination of testosterone undecanoate in microemulsion.
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