A HIGH-PRESSURE LIQUID-CHROMATOGRAPHY ASSAY-METHOD FOR ANALYSIS OF DESLORELIN AND BENZYL ALCOHOL IN DESLORELIN INJECTION

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 a lcohol) were determined from a single injection. The separation and qu antitation were achieved on a C-18 column at ambient temperature using a mobile phase of 70:30 v/v aqueous phase:acetonitrile containing sod ium hexylsulfonate and triethylamine at pH 3. The wavelengths for spec trophotometric detection were 275 mn for deslorelin and 254 nn for ben zyl alcohol. The method showed linearity, precision and accuracy for d eslorelin (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 l ower limits of quantitation for deslorelin and benzyl alcohol were 2.9 3 mu g/mL and 0.059-11 mu L/mL) respectively.