Development and validation of the methods of aciclovir and butaminofen assay in combined antiherpetic ointment Actovir®
Convenient HPLC methods of aciclovir and butaminofen assay in combined antiherpetic ointment are developed. Sample preparation conditions were determined: extraction reagents (0,1 М solution of sodium hydroxide for aciclovir and methanol for butaminofen); time and temperature regimes of extraction and number of extractions are estimated. HPLC methods of aciclovir and butaminofen assay in combined antiherpetic ointment are validated. As results of validation experiments the chromatographic system is considered to be suitable, selective, linear, repeatable, reproducible, and accurate. Analytical methods are included into pharmacopoeia monograph and are used in routine quality control of manufacturing batches of medicinal product on RUE «Belmedpreparaty».