Development and validation of a simple, fast, isocratic stability indicating RP-HPLC-UV method for the determination of chlorhexidine and its impurity para-chloroaniline in bulk and finished product

Abstract

Abstract:-A simple, isocraticRP HPLC-UV method was developed for the simultaneous determination of chlorhexidine (CHD) and p-Chloroaniline (pCA) inchlorhexidine mouth rinses. An excellent separation obtainedbyC18 column (200mm × 4.6 mm, 3μm). Mobile phasewas acetate buffer:methanol in a 45:55 ratio,flowrate was 1.0 ml/min. Both ingredient and an impuritywere detected at 254 nm,injection volume was 20µl and the analysis temperature was room temperature.Resolution4.7,retention times was3.1min and 5.7 min for pCAand CHD respectively. The proposed method was testedforsystem suitability, linearity, range, precision, accuracy, specificity, robustness, detection and quantification limits. The linearity range was40-160µg/ml forCHD and0.3-1.2 µg/ml forpCA.The correlation coefficient of the regression line was 1.000 for both components. Method robustness was tested under nine different conditions using sampleswith a known content. For CHD, the mean of the nine assays was 99.95% andthe RSD was 0.16%. ForpCA, the mean of the nine assays was 99.98% and the RSD was 0.24%. The results show that this is a simple method that can be applied to the analysis of Chlorhexidineproductswith satisfactory degrees of accuracy and precision. Due to the selected optimized conditions, this method can be used with the minimum requirements of an isocratic HPLC system.

Standardising intraoperative irrigation with 0.05% chlorhexidine gluconate in caesarean delivery to reduce surgical site infections: A single institution experience

“…Warming irrigation fluids is a common surgical process and may be impacted by surgeon discretion. The manufacturer instructions for the medical device containing 0.05% CHG in sterile water are specific to a temperature not to exceed 40°C for up to seven days because degradation of CHG is known to occur in the presence of high heat (100°C) (Mohammeda & Aziza 2017). Furthermore, duration of high temperature has also been associated with degradation (Mohammeda & Aziza 2017).…”

Quantitative determination of 0.05 % chlorhexidine solution by capillary electrophoresis

“…In this case, UV-spectrophotometry serves as a reference method in the domestic practice of quality control of given drug [11]. At the same time, foreign sources of scientific information contain data on the possibility of analyzing chlorhexidine in various drugs by acid-base titration in protogenic solvent medium, as well as using HPLC and capillary electrophoresis [10,[12][13][14]. Among these methods, capillary electrophoresis is the most promising in controlling the quality of drugs containing chlorhexidine, and its advantages are well known and described in numerous scientific works [15][16][17][18].…”