Abstract
Cetrimide (CE) is a quaternary ammonium compound and a cationic surfactant, which can be used as an antiseptic and preservative in various formulations. Antiseptic solutions of Cetrimide are available in combination with Chlorhexidine Gluconate (CHG) for external use. Chlorhexidine is a biguanide with high microbicidal activity and is widely known as a skin disinfectant. The present work displays the development and validation of an RP-HPLC isocratic method for the simultaneous determination of CE and CHG. The method consists of a Hypersil® SAS C1 (4.6 × 250 mm) 5 μm column, with a mobile phase of 85%/15% v/v MeOH-NaH2PO4·H2O, aqueous solution. In addition, 0.2% of triethylamine (Et3N) was added to the buffer for the confrontation of peak tailing, and then the pH was adjusted to 3.0 with ortho-phosphoric acid (H3PO4). The flow rate was set at 1 mL/min, and adequate detection was achieved with a diode array detector (PDA) at 205 nm. The method was successfully validated according to ICH guidelines for specificity, linearity, accuracy, precision and stability for sample and standard solutions. In addition, the robustness of the method was evaluated through statistical and graphical analysis, using a fractional factorial experimental design.
Highlights
Antiseptics and disinfectants are used to an extended degree by both individuals and hospital units, and when put to good use they can become an important tool against microbes [1]
Cetrimide (CE) falls in the category of cationic surfactants, and in the sub-category of the quaternary ammonium compounds. These compounds consist of two parts, one large hydrophobic chain and the positively charged quaternary ammonium ion, which is responsible for the antiseptic properties of these molecules [1,2]
Preparation of Stock Solution for Spiked Samples The Chlorhexidine Gluconate (CHG) 20% solution presents increased viscosity and is not recommended for use as it is in the analysis
Summary
Antiseptics and disinfectants are used to an extended degree by both individuals and hospital units, and when put to good use they can become an important tool against microbes [1]. Various chemical substances form different categories of antiseptics, due to their different structure. Cetrimide (CE) falls in the category of cationic surfactants, and in the sub-category of the quaternary ammonium compounds. These compounds consist of two parts, one large hydrophobic chain and the positively charged quaternary ammonium ion, which is responsible for the antiseptic properties of these molecules [1,2]. Chlorhexidine (CH) is the most popular substance in the category of biguanides, and due to its low toxicity, is used extensively in various commercial formulations [4]. The combination of CE and CHG has shown to be effective against a wide variety of Gram (+) bacteria and very useful in cleaning wounds, abrasions and burns and finds application in the fields of obstetrics, dentistry, gynecology and urology [7,8,9]
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