Development and validation of a stability-indicating analytical method for the quantitation of oxytocin in pharmaceutical dosage forms

Chaibva, F. A. and Walker, R.B. (2006) Development and validation of a stability-indicating analytical method for the quantitation of oxytocin in pharmaceutical dosage forms. Journal of Pharmaceutical and Biomedical Analysis, 43 (1). pp. 179-185. ISSN 0731-7085

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Official URL: http://dx.doi.org/10.1016/j.jpba.2006.07.002

Abstract

A single stability-indicating assay for oxytocin (OT) in pharmaceutical dosage forms using gradient elution over 21 min has been reported in the literature. Furthermore, published and compendial methods for the analysis of OT containing dosage forms also involve using HPLC with gradient elution and complicated mobile phases that include hydrophobic ion pairing agents. A simple isocratic and stability-indicating assay was developed and validated. The conditions are as follows, column: Phenomenex® C18 Hypersil, 5 μm packing, 4.6 mm × 150 mm with acetonitrile–phosphate buffer (pH 5; 0.08 M) (20:80) as the mobile phase with UV detection at 220 nm The method was found to be specific for OT in the presence of degradation products and chlorbutol (preservative) with an overall analytical run time of 16 min. Accuracy was determined to be 0.77–1.18% bias for all samples tested. Intra-assay precision (repeatability) was found to be 0.22–1.04%R.S.D. while the inter-day precision (intermediate precision) was found to be 1.27–1.68%R.S.D. for the samples studied. The calibration curve was found to be linear with the equation y = 1.81x + 0.02 and a linear regression coefficient of 0.9991 over the range 0.4–12.0 IU/ml. The LOD and the LOQ were determined to be 0.1 and 0.4 IU/ml, respectively. Syntocinon®, a commercially available dosage form of OT was assayed resulting in 100.5–106.6% recovery of the label claim and an average of 10.04 IU/ml.

Item Type:Article
Additional Information:Corresponding author: R.B.Walker, Rhodes University, Faculty of Pharmacy.
Uncontrolled Keywords:Oxytocin; Pharmaceutical dosage forms; HPLC; Isocratic; Stability indicating
Subjects:Y Unknown > Subjects to be assigned
Divisions:Faculty > Faculty of Pharmacy
ID Code:487
Deposited By: Mrs Eileen Shepherd
Deposited On:09 Jan 2007
Last Modified:01 Aug 2012 07:57
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