Spectrophotometric method for determination of gentamicin in bulk and pharmaceutical dosage forms using salicylaldehyde

الملخص EN

A sensitive, simple and cost effective spectrophotometric method was developed and validated for determination of gentamicin (GEN) in bulk and pharmaceutical preparations.

The method is based on schiff base condensation reaction of the primary amino group of gentamicin with salicylaldehyde reagent (SA) in presence of acetate buffer solution (pH 5.5) at 45 °C for 15 minutes.

The obtained yellow colored derivative in methanolic medium showed absorption maxima at 416 nm.

The validity of the described method was assessed according to the International Conference on Harmonization (ICH) guidelines.

The regression line equation was Y = 0.0053X + 0.0527 for the concentration range 14-170 μg/mL, and a regression coefficient 0.994 (n = 5).

The limit of detection (LOD) and limit of quantification (LOQ) were found to be 2.17 and 6.6 μg/mL, respectively.

The percent of recovery performed at three different concentrations using standard addition method was in the range 99.77-101.78 ± 0.15-1.55.

The precision of the method was satisfactory, the values of relative standard deviation (RSD) were less than 1.22%.

No interference liabilities were observed from excipients of GEN dosage forms.

The method was successfully applied for determination of GEN; the label claim percentages were 99.24 ± 1.48 and 100.53 ± 2.64 for injections and eye drops, respectively.

The results were compared favorably with a validated reference method.

The developed method is practical and valuable in terms of its application in quality control laboratories.