ABSTRACT

1. ABSTRACT The Optimation of Methanol - Water Mobile Phase at HPLC for Quantitative Analysis of The Mixture Of Theophylline and Ephedrine HCl in Tablet Rr. Ajeng Mia Rizky S The optimation of methanol - water composition as mobil phase in HPLC for quantitative analysis of the mixture of theophylline and ephedrine HCl simultaneously in tablet has been done. This work was done since theophylline concentration in tablet was too high in compare with ephedrine HCl concentration. So, determination of these substances simultaneously were difficult. The purpose of this research was to get an efficient composition of mobile phase which can separate theophylline from ephedrine HCl with good resolution (Rs > 1,5 and α > 1). Validation parameters that have been checked were linierity, accuracy and precision. The result showed that efficient composition of mobile phase were methanol - water (40 : 60). A good linierity between concentration and area of theophylline and ephedrine HCl obtained were r = 0,9962, Vxo = 3,21%; r = 0,9995, Vxo = 1,99% respectively. Precision instrument for theophylline and ephedrine HCl were 0,60 % and 1,29% respectively. Average recovery of theophylline and ephedrine HCl in the simulation matrix were 99,59 % and 99,37 % respectively. Accuracy of the methods were in the range of accepted limits (95 - 105%), The concentration of theophylline and ephedrine HCl in sample tablet were 102,33% and 93,68% respectively, these recovery were fulfil of USP XXV requirement (90 - 110 %). Key word : HPLC, methanol - water, theophylline and ephedrine HCl