Studies On Quality For Ribostamycin Sulfate

This paper studies on quality for Riobostamycin Sulfate, which is one of the aminoglycoside antibiotics. TLC was employed to detect the related substance in Riobostamycin Sulfate, and a new detector–ELSD (Evaporative Light Scattering Detector), a satisfactory method for the determination of Riobostamycin was established..And this paper did a series of work to set up the refrence substance of Riobostamycin .The whole work was prepared for the new China Pharmacopoeia. The following works have been done in this paper.First, there were few reports about the related substances in Riobostamycin Sulfate over abroad. This paper has tried times to establish a best TLC. To develop on the silica G plate, the developing solvent is 2-butanone- methanol-isopropanol-ammonia water stronger-water (10:12:3:8:2),and colored by 0.2% triketohydrindene hydrate which dissolved in the n-butanol which saturated by water. The method is simple for the quality control of the preparation, and has a good specificity. Then, a new detector-ELSD was established to detect related substances in Riobostamycin Sulfate. Dionex Acclaim C18(4.6mm×250mm,5μm ) column as stationary phase, 20mmol/L ammonium acetate solution( concluding 0.8% pentafluoropropionic acid )and methanol(55:45) as mobile phase, detected with Evaporative Light–Scattering Detector. The established method of the relative substance detection had good linearity within the range of 3.9893μg/ml~35.904μg/ml(r=0.9995).Second, for the determination of the content of Riobostamycin Sulfate,5 batches of Riobostamycin Sulfate and 6 batches of Riobostamycin Sulfate for Injection were determined with HPLC-ELSD and microbial assay respectively. The concent detected by microbial assay was higher than HPLC-ELSD This showed the HPLC-ELSD can remove the interference of Neamine, and HPLC-ELSD was more rigorous and better than microbial assay.Third, set up the reference substance of Riobostamycin with the rules about the single antibiotics. After subtracting the organic admixture, moisture content, evaporator component and ash content, the principal constituent was the purity of Riobostamycin.