Abstract
Chlorhexidine (CHX) is a broad-spectrum antiseptic that is used in many topical pharmaceutical formulations. Because there is no official microbiological assay reported in the literature that is used to quantify CHX, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method for the dosage of chlorhexidine digluconate (CHX-D) in an aqueous solution. The assay is based on the inhibitory effect of CHX-D upon the strain of Staphylococcus aureus ATCC 25923, which is used as the test microorganism. The design 3x3 parallel-line model was used. The results were treated statistically by analysis of variance (ANOVA), and they were excellent in terms of linearity (r = 0.9999), presenting a significant regression between the zone diameter of growth inhibition and the logarithm of the concentration within the range of 0.5 to 4.5%. The results obtained were precise, having relative standard deviations (RSD) for intra-day and inter-day precision of 2.03% and 2.94%, respectively. The accuracy was 99.03%. The method proved to be very useful and appropriate for the microbiological dosage of CHX-D in pharmaceutical formulations; it might also be used for routine drug analysis during quality control in pharmaceutical industries.
Highlights
Antiseptics are products that are used to clean and disinfect traumatic wounds, burns, mucous membranes, Chlorhexidine (CHX) is an excellent cationic antiseptic that belongs to a class of drugs called biguanides and has the chemical name (1,1’-hexamethylenebis{5(p-chlorophenyl)biguanide)} (Buxbaum et al, 2006; USP, 2008; BP, 2010; EP, 2011)
The aim of the present study was to develop and validate a simple, sensitive, precise and accurate microbiological assay by agar diffusion using a template method to quantify CHX-D in aqueous solution as an ecological alternative to the physicochemical methods described in the literature
Microbiological assays have the potential to prevent the possible loss of activity, while physicochemical methods do not prevent the loss of the antimicrobial potency (USP, 2008)
Summary
Antiseptics are products that are used to clean and disinfect traumatic wounds, burns, mucous membranes, Chlorhexidine (CHX) is an excellent cationic antiseptic that belongs to a class of drugs called biguanides and has the chemical name (1,1’-hexamethylenebis{5(p-chlorophenyl)biguanide)} (Buxbaum et al, 2006; USP, 2008; BP, 2010; EP, 2011). It exists as a variety of salts, including acetate, gluconate, hydrochloride. The CHX exhibits minimal activity; against endospores and cysts of protozoa the activity is nil (Fiorentino, Corrêa, Salgado, 2010; Cone et al, 2006; Martindale, 2009)
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