DEVELOPMENT AND VALIDATION OF THE SPECTROPHOTOMETRIC METHOD OF QUANTITATIVE DETERMINATION OF ENISAMIUM IODIDE IN CAPSULES
DOI:
https://doi.org/10.11603/2312-0967.2017.2.7894Keywords:
enisamium iodide, capsules, assay, spectrophotometry, validation.Abstract
The aim of the work. The work is devoted to development of the method for quantitative determination of enisamium iodide in capsules using the method of ultraviolet absorption spectrophotometry.
Materials and Methods. The reference standard of enisamium iodide and the sample of finished drug product produced by Farmak JSC were used. The working concentration of enisamium iodide 0.02 mg/ml was established. The study was carried out using the spectrophotometer «Specord 250 Plus».
Results and Discussion. The optimal wavelength for determination was found to be 267 nm. The method validation characteristics such as specificity, accuracy, precision, linearity, range, robustness, intermediate precision were studied in accordance with recommendations of the International Conference on Harmonization in the range of 0.016-0.024 mg/ml (80-120 %). The correlation coefficient between the fitted and observed values for enisamium iodide was high (r = 0.99996), at the same time the relative confidence interval was low (Az = 0.23 %). Solutions were confirmed to be stable for 48 hours at the room temperature.
Conclusions. The spectrophotometric method of enisamium iodide assay in capsules was developed, experimentally was established that the described method can be used for quality control of enisamium iodide capsules.References
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