Identification of azoles antifungics in compounded pharmaceuticals for HPLC-UV

Abstract

 The polyenes and azoles antifungals comprise the imidazoles that are represented by miconazole nitrate and ketoconazole, and the triazolics are represented by fuconazole and itraconazole. They are widely prescribed for the treatment of systemic infections caused by fungi, especially in immunocompromised patients. The compounded pharmaceuticals are developed to attend individualized treatment and in Brazil they are regulated by the RDC No. 67 which established the Good Practices for Manipulated of Magistrates and Officinal Preparations for human use in Pharmacy (GPMP). The institute received samples of manipulated capsules identified as fluconazole to verify the identity of the product. The method employed was ketoconazole essay from USP-28 which have the following modifications: column, length wavelength, flow, temperature at 25ºC;the mobile phase was adjusted to pH 5.6 with glacial acetic acid. used: Shimadzu HPLC CLASS-VP10, standards of miconazole nitrate and the bases of fluconazole, itraconazole, ketoconazole, secnidazole, tioconazole and metronidazole. These standards were prepared at concentration 100µg/mL, as well as the solutions of the individual contents of the capsules. After the chromatographic development of the samples and the standards, retention times were not similar between the capsules and standards. Conclusion was that the content of the capsules was not fluconazole. The chromatographic system proved effective in identification of six antifungals that have similar chemical structures and they showed different times of elution just like the antiparasitic metronidazole which has different chemical structure. This method could be a choice for the analysis of antifungal if there were complaints about the identity of the drug.