Fiber-Optic Chemical Sensor Based On UV/VIS Absorption For Monitoring Drug Dissolution

Objective: Drug Dissolution is rate and degree of dissolution which is from solid dosage forms such as tablets and capsules so on at specified solvent.Dissolution testing for pharmaceutical products in tablet and capsule form is required by the Unite State Pharmacopoeia (USP) in 1970. It is also required by Chinese Pharmacopoeia (Ch.P) in 1985.Dissolution testing is an important tool for quality control and an aid in developing pharmaceutical formulations. It measures changes in the stability of the product. In recent thirty years, increasingly new druggery species are required to carry out Dissolution testing, and the methods of measurement are being improved step by step. Traditionally, Dissolution testing has been conducted by manually or automatically removing samples from dissolution vessels,and then bringing the samples either to a UV/VIS spectrometerfor determination of the analyte concentration.The field of recent growth in dissolution testing equipment is fiber optic chemical sensor in 90's of last century. A real-time drug levelof dissolution is determined in-situ or in the vessels without sample removal.Methods: This thesis establishes measures methods which are about 15 species druggery based on the UV/VIS absorbance with Fiber-Optic Chemical Sensing Drug Dissolution Test (FOCSDT). The absorbance measurements are corrected for turbidity-related scatter using the baseline。 measures methods include precision and recovery of these methods, comparison parameters of dissolution for Ch.P and FOCSDT.Results: 1 FOCSDT can test Phenoxymethylpenicillin Potassium Tablets so on directly according to Ch.P.2 FOCSDT can establish proces- sing analysis methods for thedissolution test of VB2 Tablets and Tinidazole Tablets by changing wavelengths.3 FOCSDT can accomplish processing analysis methods for the dissolution test of Chlorpromazine Hydrochloride Tablets and Aminophylline Tablets by changing solvent pH.4 FOCSDT can accomplish processing analysis methods for the dissolution test of Zinc Gluconate Tablets by adding developer. 5)Theoretic formularies of Standard curve and Lightlength are deduced according to the drug's label amount and E.Conclusion: The parameters were obtained directly from the dissolu- tion profile. And the control experiment was conducted as described by the Chinese Pharmacopoeia. No difference was found between the two methods (P>0.05). The system is more accurate, precise, and easier to set up than conventional manual sampling or automated sipper-sampling systems and analysis using spectrophotometry. FOCSDT eliminates the withdrawal of sample aliquots and provides the in-situ measurement of drug concentrations eliminates the problems inherent in withdrawing sample from the vessel for further analysis. The in-situ system also eliminates the need tore place media and the resulting volume correction calculations. It is very important for immediate release experiment and sustained release preparation especially.