DEVELOPMENT AND VALIDATION OF THE SPECTROPHOTOMETRIC METHOD OF QUANTITATIVE DETERMINATION OF ENISAMIUM IODIDE IN CAPSULES

Authors

  • О. V. Burmaka Farmak JSC, Kyiv
  • S. M. Gureyeva Farmak JSC, Kyiv
  • V. M. Margitich Farmak JSC, Kyiv

DOI:

https://doi.org/10.11603/2312-0967.2017.2.7894

Keywords:

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.

Author Biographies

О. V. Burmaka, Farmak JSC, Kyiv

Farmak JSC, Kyiv

S. M. Gureyeva, Farmak JSC, Kyiv

Farmak JSC, Kyiv

V. M. Margitich, Farmak JSC, Kyiv

Farmak JSC, Kyiv

References

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Published

2017-07-04

How to Cite

Burmaka О. V., Gureyeva, S. M., & Margitich, V. M. (2017). DEVELOPMENT AND VALIDATION OF THE SPECTROPHOTOMETRIC METHOD OF QUANTITATIVE DETERMINATION OF ENISAMIUM IODIDE IN CAPSULES. Pharmaceutical Review Farmacevtičnij časopis, (2), 64–71. https://doi.org/10.11603/2312-0967.2017.2.7894

Issue

Section

Analysis of drugs