Determination Of Tylvalosin Tartrate In Original Medicine And Premix By Antibiotic Microbial Assay

Tylvalosin tartrate is a macrolide antibiotic,mainly used for the prevention and treatment of mycoplasma in pigs and chickens.The current "Veterinary Drug Quality Standards"(2017 edition)have stipulated the characteristics,identification,inspection,content determination,action and use,usage and dosage,precautions,withdrawal period,specifications,storage and so on of tylvalosin tartrate and its dosage forms.The determination method of the content of tylvalosin tartrate was antibiotic microbiological assay.Microbiological assay of antibiotics can directly display the antimicrobial titer of antibiotics and it is an indispensable method for the determination of multi-component antibiotic content.The current standard stipulates that the potency of tylvalosin tartrate API should not be less than 8 million tylvalosin units per 1mg and the content of component tylvalosin A should not be less than 80%.The content of Tylvalosin tartrate premix is 90%～110%of the labeled amount.The quality control of tylvalosin tartrate is directly related to the quality of tylvalosin tartrate.In order to demonstrate the determination method of effective content in tylvalosin tartrate and premix.This study intends to verify the methodology for the determination of the effective content of tylvalosin tartrate and premix by the antibiotic microbiological assay method.To examine the linear relationship,accuracy,precision,specificity,and durability.This method was used to detect the content of tylvalosin tartrate crude drug samples from different manufacturers and batches.In order to provide a reference for the improvement of the national veterinary drug testing standards for tylvalosin tartrate remix.In this study,an antibiotic microbial assay method was used to detect the effective content of tylvalosin tartrate.The concentration of tylvalosin tartrate was well linear in the range of 2-10IU/mL.The content of 6 parts of tylvalosin tartrate of the same quality was determined.The results were all greater than 800IU/mL,the RSD was 0.84%,and the precision was good.Different incubation times had a small influence on the RSD of the determination result of 1.24%,and the RSD of the three different manufacturers’ media content determination results was 0.80%.The difference is small.Therefore,different brands of culture media have little effect on the results,and the method has good durability.It shows that the method is suitable for the determination of tylvalosin content in tylvalosin tartrate raw materials.This method was used to detect the content of different batches of tylvalosin tartrate raw materials from different manufacturers,and the results were all.The results are all greater than 800IU/mg,which meets the requirements of current standards.In this study,an antibiotic microbiological assay method was used to determine the effective content of tylvalosin tartrate premix.The results showed that the concentration of tylvalosin tartrate was well linear in the range of 2～10IU/mL 5%tylvalosin tartrate.The average recovery rates of the premix and 20%tylvalosin tartrate premix were 99.72%and 100.24%,respectively,and the RSD were 1.08%and 1.21%,respectively.The accuracy was good.The precision results were RSD was 0.68%and 1.15%.The precision is good.The excipients have no influence on the content determination,and the specificity is good.The results of the different culture time are 0.89%and 1.94%,and the RSD of the medium of different manufacturers are 0.54%and 0.20%,respectively.The method has good durability.This method is suitable for the detection of the effective content of tylvalosin tartrate premix.This method was used to test the content of tylvalosin tartrate premixes of different batches and specifications from different manufacturers,and the results were all between 90%and 110%of the labeled amount,which met the requirements of current standards.