A Stability-Indicating HPLC Method for the Determination of Oxytocin Acetate in Oxytocin Injection, USP, Synthetic

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Abstract
A gradient high performance liquid chromatographic (HPLC) procedure employing ultraviolet (UV) detection for the analysis of oxytocin acetate in Oxytocin Injection, USP, Synthetic is reported. The method requires no sample pretreatment and is accurate, reproducible and selective. The peak area versus oxytocin acetate concentration is linear over the range of 50–150% of its label claim of 10 Oxytocin USP Units/mL. The mean absolute recovery of oxytocin acetate using the described method is 98.3 ± 0.6%, (mean ±SD, n = 9). The precision, relative standard deviation (RSD), of label claim, amongst five sample preparations is not more than 0.4%. Intermediate precision, as determined from fifteen sample preparations, generated by two Analysts on different HPLC systems over three days, exhibits an RSD of 1.9%. The Standard and Assay Preparations are stable for up to 48 hours at room temperature. The selectivity was evaluated by subjecting the finished product (Oxytocin Injection, USP, Synthetic) to thermal, acidic, basic, oxidative and fluorescent radiation stress conditions. No interference in the analysis of oxytocin acetate was observed from degradation products or from the preservative, chlorobutanol, showing the method is stability-indicating.