Study On Components Of Nyfungin And Consistency Evaluation Of Calcium Gluconate Tablets

ObjectiveRT6 is an unknown component of Nyf and will be further confirmed and quantified.Ca G,no-reference preparations,is designed consistency evaluation to follow the instructions.The quality and efficacy of Ca G tablets will be improved by technique innovation.MethodsAll components and the molecule ion peaks of RT6 were determined by LC-MS/MS.The Pre-HPLC method was established to separate RT6 and the qualitative and quantitative analysis of RT6 was further carried out by UV and q NMR.The HPLC methods for related substances and determination of gluconic acid were established in order to control the quality of Ca G tablets.Calcium content was determined by complexometric titration and friability was investigated.The dissolution rate of Ca G tablets was respectively investigated in water,hydrochloride buffer solution with p H 1.2,acetate buffer solution with p H 4.0,and phosphate buffer solution with p H 6.8 by the paddle method and determined by AAS method.Appling related substances,content,friability,dissolution rate and stability to evaluate the quality of self-made tablets.Self-made tablets formulation was optimized by means of single factor design to change contents of the diluents,the glidants and the lubricants.ResultsThe molecular formula of RT6 was C15H16N2O2 and relative molecular weight was 256.12.RT6 content of Nyf bulk drug in three production batch's samples were 4.29%,4.21% and 4.10% respectively.HPLC method for related substances and content of gluconic acid and determination of dissolution rate were successfully.There were unqualified in different batch's samples for tablet friability,which had significant differences.The optimal formulation was obtained by single factor design for 1.0% diluents,2.0% glidants and 0.9% lubricants.The stability,appearance,content,related substances,dissolution rate and friability of self-made tablets were qualified.ConclusionsStructural identification and quantitation of RT6 provided some methods and technologies to other components study,and enhanced quality standards.The evaluation methods of Ca G tablets were established and optimized.The related substances,content,friability and dissolution rate for self-made tablets were up to the standard.It provided a reference to consistency evaluation of other drugs.