Compatible Stability Study Of Amiodarone Hydrochloride Injection Combined With Four Injections

Purpose: to study the compatible stability of amiodarone hydrochloride injection with four clinically commonly used injections, i.e. 0.9% Sodium Chloride, 5% glucose, 10% glucose, and NaCl glucose.Method:1.Formulation of sample solutionBased on the ranges of pH values of the four types of injection, as stipulated in Chinese Pharmacopoeia ( second issue in 2010), use Nacl solution and NaOH solution to adjust the pH values of 0.9% Sodium Chloride, 5% glucose, 10% glucose, and Nacl glucose to 5.5 and 7.0, 3.2 and 6.5, 3.2 and 6.5 as well as 3.5 and 5.5 respectively. Based on the clinically commonly used dosage, add two amiodarone hydrochloride injections respectively into the above 8 adjusted solutions and the 4 unadjusted solutions to get 12 types of sample solutions.2.Test of pH values of the sample solutions: take sample solutions under Item 1 ,measure their pH values in time of 0, 0.5, 1, 2, 3, 4, 5 and 6 hours and observe and record the changes in appearance (color, clarity) of the solutions.3.Study of the compatible stability of amiodarone hydrochloride injection with four injections.3.1 Experiments on specificity: take reference solution and dilute it by mobile phase solution to 0.6mg/mL, inject 1μL, and take 1μL of 0.9% Sodium Chloride, 5% glucose, 10% glucose, and NaCl glucose respectively to compare their chromatography.3.2 Standard curve and linear range: take one 0.15g/3mlamiodarone hydrochloride and dilute it to 0.15 mg /ml,0.3 mg /ml,0.6 mg /ml,1.2 mg /ml,1.8 mg /ml,2.4 mg /ml respectively using mobile phase solutions, measure under the above chromatography, and record the peak areas and get linear regression of concentration of amiodarone hydrochloride (C) with peak areas of the chromatography (A).3.3 Study of RSD: take 0.6mg/mlreference solution, inject five times with 1μL each and record the peak areas and calculate RSD.3.4 Study of the compatible stability of amiodarone hydrochloride injection with four injections: before the mixture, measure and record the pH values of 0.9% Sodium Chloride, 5% glucose, 10% glucose, and NaCl glucose, and measure their pH values after the mixture in time of 0, 0.5, 1, 2, 3, 4, 5 and 6 hours respectively. In the mean time, under the chromatography as stated under the above chromatography, inject 1μL respectively and record the peak areas of amiodarone hydrochloride and the changes in appearance (color, clarity) of the solutions.Results:1.Measurement of compatible sample solutions: within 6 hours of mixture, pH values and appearances experienced no visible change.2.study of compatible stability of amiodarone hydrochloride with four injections2.1 specificity test result: the retaining time of amiodarone hydrochloride was 9.6 minutes under the experimental conditions.2.2 standard curve: when concentration of amiodarone is between 0.15~2.4mg/mL, peak area and concentration are of linear relations and the regression formula is: A=4E+06C-8809.3(R2=1).2.3 RSD test results: the RSD% of amiodarone was 0.1% during the day, indicating the repeatability of the experiment method.2.4 Content test result: result shows the content of amiodarone had no visible change with 6 hours.Conclusion:The Experiment indicates amiodarone hydrochloride remains stable in 6 hours when mixed with 0.9% Sodium Chloride, 5% glucose, 10% glucose, and NaCl glucose of different pH values.