Objective: To investigate the compatible stability of roxatidine acetate hydrochloride (ROX) for injection with glucose sodium chloride injection

xylitol injection

fructose injection

invert sugar injection and 10% glucose injection. Methods: After the combination of ROX for injection and five solvents

samples were taken at 0

1

2

4

6

8

12

24 h at room temperature (25±1) °C and high temperature (40±1) °C

the appearance of the mixed infusions were observed

the pH value and the number of insoluble particles were measured

and the content of ROX was determined by high performance liquid chromatography. Results: Under the above conditions

the appearance of each of the compatibility solution was clear and transparent

no bubbles and precipitates were produced. There was no significant change in pH of each compatibility solution

RSD<2% (n=8). However

the pH of the compatibility of the drug and glucose sodium chloride injection solution were 3.96 and 3.91 after 12 and 24 h at room temperature

the pH values were 3.95

3.92 and 3.86 after 8

12 and 24 h at high temperature

and the pH values of other compatibility solution ranged from 4.40 to 6.31. The insoluble particles of compatibility solution did not increase significantly within 24 h

and all met the requirements. The drug content changes in the mixture of ROX and xylitol injection

fructose injection

invert sugar injection

10% glucose injection within 24 h were <5%

RSD<2%. The content of the combination of ROX and glucose sodium chloride injection showed the downward trend

the drug content changed by >10% within 24 h

the RSD was 4.52% (room temperature

n=8) and 4.43% (high temperature

n=8). Conclusion: ROX for injection combination with xylitol injection

fructose injection

invert sugar injection and 10% glucose injection should be used within 24 h

and combination with glucose sodium chloride injection should be used within 12 h.