European Journal of Biomedical and Pharmaceutical Sciences

SIMULTANEOUS ESTIMATION OF CHLORHEXIDINE DIGLUCONATE AND MICONAZOLE NITRATE BY RP- HPLC

Rubeena Mubeen S.*, Abhilekha P. Mantri, Sandeep Kumar Singh and Shiva Kumar

ABSTRACT

A new RP-HPLC method was developed and validated for the simultaneous determination of chlorhexidine digluconate and miconazole nitrate in a shampoo formulation. The chromatographic separation was achieved by gradient mode with 0.3% Orthophosphoric acid and Acetonitrile, as mobile phase and using RP C-18e (25.0 cm × 4.6 mm i.d, 5μ particle size) column as stationary phase, with a flow rate of 1.0 ml/min at 35oC. The quantification of the analytes was monitored by UV detection at a wavelength of 225 nm. The optimized method was subjected to validation for specificity, accuracy, precision, linearity range, ruggedness and robustness. The calibration graphs were linear in the concentration range of 0.00010 – 0.00015 mg/ml for chlorhexidine digluconate and 0.00012 – 0.00018 mg/ml for miconazole nitrate. The results were evaluated as per the International Conference on Harmonization (ICH) guidelines. The precision of the method in terms of RSD is not more than 2% for both the analytes. The method is sensitive, specific, fast and accurate with minimum sample preparation.

Keywords: Chlorhexidine digluconate; Miconazole nitrate; HPLC method; Shampoo.