Development and validation of novel rapid stability indicating mass compatible UPLC method for the simultaneous estimation of assay and related substances of oxytocin bulk and assay of injectable dosage form

Abstract

Developed and validated a simple, rapid, new mass compatible reverse phase ultra-performance liquid chromatography (UPLC) method for the simultaneous estimation of Assay and related substance of Oxytocin in bulk and extending the same method to injectable dosage form for the estimation of Assay. The developed method is capable of separating all the potential process and degradation impurities within 15 minutes. Chromatography was carried out using Waters Acquity CSH C18 column (50 mm length, 2.1 mm internal diameter and 1.7μ particle size) with gradient elution. 0.1% Trifluoroacetic acid used as Mobile phase A and mixture of 0.1% Trifluoroacetic acid and Acetonitrile in the ratio of 50:50 v/v was used as Mobile phase B. The flow rate of the mobile phase was set at 0.4 mL/min and the column temperature was maintained at 35°C. The detection was carried out using UV detector at 220 nm. The Retention time of Oxytocin is about 3 minutes and all the potential impurities are eluted within 10 minutes. Method validation was performed according to ICH (International Conference on Harmonization) guidelines. The validated method is simple, rapid, mass compatible, economical, specific, accurate, linear, precise, rugged, sensitive, robust and stability indicating.