A High Pressure Liquid Chromatography Assay Method for Analysis of Deslorelin and Benzyl Alcohol in Deslorelin Injection

Abstract Deslorelin is a nonapeptide drug used for precocious puberty in young women. A reversed phase HPLC procedure was developed for the analysis of deslorelin and benzyl alcohol in a parenteral solution dosage form. Both the nonapeptide drug (deslorelin) and the preservative (benzyl alcohol) were determined from a single injection. The separation and quantitation were achieved on a C18 column at ambient temperature using a mobile phase of 70:30 v/v aqueous phase:acetonitrile containing sodium hexylsulfonate and triethylamine at pH 3. The wavelengths for spectrophotometric detection were 275 nm for deslorelin and 254 nm for benzyl alcohol. The method showed linearity, precision and accuracy for deslorelin (2.93–550 mg/mL) and benzyl alcohol (0.059–11 mL/mL) over a large concentation range (0.6%–110% of the label concentration). The lower limits of quantitation for deslorelin and benzyl alcohol were 2.93 g/mL and 0.059 l/mL respectively.