Development and validation of a method for quantitative determination of Acyclovir in a new antiviral ointment based on tizol gel

The low penetrating ability of antiviral drugs with acyclovir through the skin barrier is one of the reasons for their limited effectiveness. Therefore, new dosage forms with improved bioavailability, such as ointments based on tizol gel, are becoming a promising area of pharmaceutical development. A prerequisite for the creation and introduction of new drugs into medical practice is the availability of validated quality control methods. Objective - to develop a spectrophotometric method for the quantitative determination of acyclovir in the ointment "Acyclozol", made on tizol gel. Materials and methods. The analysis was performed using acyclovir substance, tizol gel, Aciclozol ointment (0.5 g of antiviral agent in 9.5 g of tizol gel). To carry out the research, spectrophotometry in the ultraviolet region was used using an SF-2000 spectrophotometer. The validation of the methodology was carried out in accordance with the State Pharmacopoeia of the Russian Federation XV edition, OFS.1.1.0012. Results. During the registration of acyclovir absorption spectra, it was found that the spectrophotometric determination of the antiviral agent should be carried out at a wavelength of 253 nm. The linear relationship between acyclovir concentration and optical density has been confirmed. The equation of the calibration graph is calculated. The content of acyclovir in the mild dosage form of "Acyclozol" is in the range of 0.4897-0.5375 g. The relative error of the analysis is not more than ± 1.87%. The proposed method of quantitative analysis of acyclovir is valid in terms of parameters - specificity, accuracy, precision and linearity in the analytical field. Conclusion. Using UV spectrophotometry, a method for estimating the quantitative content of acyclovir in a new antiviral ointment based on tizol gel has been developed and validated.

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