Abstract
The aim of the present study was to develop and validate HPLC method for determination of related substances of benzydamine hydrochloride in a dosage form, containing benzydamine hydrochloride as an active substance. A new selective, specific and sensitive method was developed for determination of benzydamine degradation products in the formulation. Determination was carried out by reversed-phase HPLC using isocratic solvent elution. The method was validated and found to be precise, accurate and specific; the detector response was linear over 0,05% - 1.2% relative to the nominal concentration of benzydamine hydrochloride in the formulation. The developed HPLC method is useful for determination of benzydamine hydrochloride related substances in formulations and can be applied in Quality Control Laboratories.
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