Quantitative Assessment of the Active Ingredient of Artemether Injection Products Before and After Induced Degradation

Author(s):

Darius Bulus*

The induced degradation profile of artemether injection products was accomplished with chromatographic separation using C18 column (25 cm × 4.6 mm) material 5 μm size with mobile phase combination of acetonitrile and water in the ratio of 62:38, a flow rate of 1.5 mL/min, and detection wavelength of 216 nm. The regression equation was found to be y=2.026 × +0.177 with R^2 value of 0.9976, and an accuracy of 0.42% RSD. The assay specification limit for interday precision was found to be 1.26% RSD while the intra-day was 0.83% RSD establishing the validity of the method for linearity, accuracy, and precision respectively. The percent contents of the active pharmaceutical ingredients of each sample before degradation ranges from 92.8% to 129.3% resulting in five samples (C, D, I, J, and M) having percent contents that complies with the international pharmacopeia standard (IPh) of 90.0 to 110.0%. It was found that ten (10) of the samples (A, B, E, F, G, H, K, L, N, and O) had higher percent artemether contents out of the fifteen (15) analyzed samples. The results of forced degradation in photolytic environment at 366 nm ranges from 0.4 to 34.9% indicating that the samples were more stable in the photolytic environment, with the exception of sample N and K with 34.9% and 23.8% percent degradation. The result of the degradation pattern in thermal environment at 70? had a range of 18.9% to 54.4%. Furthermore the results of forced degradation in acidic environment (5.0 NHCl for 30 min at 70?) ranges from 14.0% to 85.5% indicating that the samples were unstable in the acidic environment, with the exception of sample M with 14.0% percent degradation. Also the result of the degradation pattern in basic environment (5.0 N NaOH for 30 min at 70?) had a range of 29.9 to 62.7%. All the analyzed samples with the exception of sample M in acidic and basic environment were found to be above the 20% maximum acceptance criteria of the International Conference on Harmonization (ICH). The result of the statistical analysis of the samples shows a significant difference at p<0.05 across each degradation environment.