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

Abstract

In the current study, a simple, reliable, and quantitative HPLC analytical method was designed to determine Hexamidine Di isethionate (HEX), Chlorhexidine Digluconate (CHX), and p-chlorocresol (CSOL) in various dosage forms including mouthwash and intimate douche in addition to chlorhexidine determination in spiked human saliva. HEX, CHX, and CSOL were determined in colored 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 0.02 µg/mL, 0.47 µg/mL & 0.03 µg/mL 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.