LC–UV Method with Pre-Column Derivatization for the Determination of Ciclopirox Olamine in Raw Material and Topical Solution
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A rapid, simple and sensitive liquid chromatographic method has been developed to assay ciclopirox olamine in raw material and topical solution. The analysis used a reversed-phase C18 end-capped column, with UV detection at 305 nm and pre-column derivatization with dimethyl sulphate. A linear response (r 2 > 0.999) was observed in the range of 0.4–200 μg mL−1. The method showed good recoveries for the raw material and topical solution and the relative standard deviation intra and inter-day were ≤2.00%. Validation parameters such as specificity and robustness were also determined. The proposed method provided an accurate and precise analysis of ciclopirox olamine in raw material and topical solution.
KeywordsColumn liquid chromatography Derivatization and validation Ciclopirox olamine
The authors would like to thank the Comissão Permanente de Revisão da Farmacopéia Brasileira for the financial support.
- 6.The United States Pharmacopoeia, 29 edn, United States Pharmacopoeial Convention, Rockville (2006)Google Scholar
- 7.Walash MI, Rizk MS, Eid MI, Fathy MES (2006) Acta Pharm 56:431–440Google Scholar
- 10.Mertin D, Lippold BC (1997) J Pharm Pharmacol 49:866–872Google Scholar
- 13.Coppi G, Silingardi S (1992) Il Farmaco 47:779–786Google Scholar
- 16.BRASIL, Resolução RE 899, de 29 de maio de 2003. Guia para validação de métodos analíticosGoogle Scholar
- 17.ICH-International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Text on validation of Analytical Procedures Q2B: Methodology, 1996Google Scholar