Analytical in-house method validation for determination of permethrin (trans & cis isomers), methyl paraben, propyl paraben and BHT

Permethrin is a drug used to cure pediculosis known as head lice. This drug is available in two forms: 1) permethrin topical cream 5%, 2) permethrin shampoo 1%. The aim of this study was to find a method and define the simultaneous cis and trans isomers for permethrin, methyl paraben, propyl paraben and butylated hydroxytoluene in topical cream 5% using the method high-performance liquid chromatography.

In order to analyze the measuring method, 5 concentration of samples and concentration of permethrin 5% have been provided, which each were injected to HPLC machine. Three times and the validity index such as selectivity, linearity, accuracy and correctness is analyzed.

According to the results of chromatographs, selectivity, linearity, accuracy and correctness were considered as acceptable areas.

Regarding the point that there is no pharmacopeia method to define the ingredients in permethrin cream simultaneously, it is so important to find an efficient analysis method to identify the peak of all ingredients in one chromatogram, considering the industrial production, time saving and increased efficiency of production units. Meanwhile the method was validated to insure that the results are correct, accurate, assurable and repeatable.