Stability of Trisodium Citrate and Gentamicin Solution: DISCUSSION


The HPLC methods used for analysis of gentamicin and citrate proved acceptable, and for both methods the validation studies indicated suitable linearity over an acceptable range, as well as suitable accuracy and precision. The specificity of the methods was established by means of forced degradation, and the peaks for the degradation products all had retention times well separated from those of the analytes. There were no changes in peak symmetry or retention times for parent compounds over the validation period. The presence of citrate was shown to not interfere with the analysis of gentamicin, and the presence of gentamicin was shown to not interfere with the analysis of citrate.

For none of the formulations (gentamicin alone, citrate alone, gentamicin and citrate combined) were there any signif­icant changes in concentration of either gentamicin or citrate over the 112-day study period. buy female viagra


The results of this study indicate that an admixture of gentamicin and citrate at final concentrations of 2.5 and 40 mg/mL (4%), respectively, can be mixed and stored in polyethylene syringes and is stable at room temperature for at least 112 days with minimal change to the initial concentra­tions. In assigning a beyond-use date, however, sterility aspects of the product must also be considered, as outlined by the US P. This information will allow extemp oraneous compounding of this catheter lock solution in advance of use and will provide a stable product for use in clinical applications.


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