HPLC Method for Determination of Chlorhexidine in Pharmaceutical Formulations alone and in presence of Hexamidine and p-chlorocresol, and in Spiked Human Saliva

Document Type : Original Article

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Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abasia, 11566, Cairo, Egypt

Abstract

In the current study, a simple, reliable, and quantitative HPLC analytical method was designed to determine Hexamidine Di isethionate (HEX), Chlorhexidine Di gluconate (CHX) and p-chlorocresol (CSOL) in various dosage forms including mouth washes and intimate douches in addition to chlorhexidine determination in spiked human saliva. HEX, CHX and CSOL were determined in coloured aqueous formulations without any sample pre-treatment or extraction steps. The proposed method showed linearity over a concentration range of 0.10 to 25.00 µg/ml of pure HEX, 2.00 to 30.00 µg/ml of pure CHX, and 0.10 to 30.00 µg/ml of pure CSOL and a detection limit of 0.023, 0.057 & 0.026 for HEX, CHX and CSOL respectively. The recoveries for Cyteal® were 100.43 % ± 1.70, 99.06 % ± 0.69 & 98.74 % ± 1.06 for HEX, CHX and CSOL respectively, whereas, for Hexitol® recovery was 100.79 % ± 1.57 for CHX. Furthermore, the proposed method has been employed to detect CHX in spiked human saliva with a recovery of 101.69 % ± 1.38.

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