Development and Validation of a RP-HPLC Method for the Simultaneous Determination of Silver Sulfadiazine and Sodium Hyaluronate in the Presence of Methyl and Propyl Paraben in a Pharmaceutical Cream for Burns.

Abstract

A direct and precise isocratic RP-HPLC method for simultaneous determination of silver sulfadiazine (SSD) and sodium hyaluronate (SH) in the presence of methyl (MP) and propyl parabens (PP) was developed and validated. Agilent chromatograph with X-Select C18 column (250 × 4.6 mm2, 5 μm) was used. Chromatographic separation was achieved using a mobile phase consisting of acetonitrile and 0.05 M phosphate buffer (pH 5.0 to which added triethyl amine 0.5 ml/L), at a ratio 35: 65 v/v. Elution was used at flow rate of 1.0 mL/min at ambient temperature with UV detection at 205 nm. The retention times for SH, SSD, MP and PP were 1.49, 3.3, 6.7 and 19.5 min, respectively. The presented chromatographic method was fully validated in accordance with ICH requirements, it was valid over linearity ranges of (0.80-100.00 μg/mL) and (3.20-100.00 μg/mL) for SSD and SH, respectively. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges and the sensitivity of the method, as the limits of detection and quantification for each active ingredient was also determined. The validated method was successfully applied for the quantification of SSD and SH in pharmaceutical cream formulation and the mean recovery % ± SD were 100.93 ± 0.985 and 100.05 ± 0.668 for SSD and SH; respectively, indicating satisfactory accuracy of the method.