Development and validation of the method for the quantitative determination of acyclovir and miramistin in a soft dosage form
DOI:
https://doi.org/10.24959/uekj.20.30Keywords:
standardization, acyclovir, miramistin, quantification, validation methodAbstract
Topicality. The main components of a drug affecting its quality, efficacy and safety are active pharmaceutical ingredients. Combined drugs include active substances, which pharmacological effect can be directed to one or more aspects of the pathogenetic process. Active pharmaceutical ingredients can have both similar and different physicochemical properties. When developing a new drug for the treatment of herpes viral diseases we used the substances acyclovir and miramistin. An important stage in the complex of research works on creation of a new drug is standardization, which includes setting the requirements for the quality of the substances used.
Aim. To develop and validate the method for the simultaneous quantification of acyclovir and miramistin, which are the active substances of a new combined drug.
Results. The value of the correlation coefficients for acyclovir and miramistin satisfies the requirements of the acceptance criterion and confirms the linear relationship between the “introduced” and “found” amount of test substances within the whole range of the concentrations studied (80-120 %). It has been found that the method of determination of active substances meets the requirements of precision at the level of convergence. Using high performance liquid chromatography it has been determined that the content of acyclovir in the test form is in the range from 47.5 mg to 52.5 mg, while the content of miramistin – from 4.75 mg to 5.25 mg.
Conclusions. The method for the quantitative determination of acyclovir and miramistin in the soft dosage form using high performance liquid chromatography has been developed. The validation characteristics studied confirm specificity, linearity, precision and accuracy of the method proposed.References
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