Development and validation of a direct, non-destructive quantitative method for medroxyprogesterone acetate in a pharmaceutical suspension using FT-Raman spectroscopy

• Published in: European journal of pharmaceutical sciences Vol. 23; no. 4; pp. 355 - 362
• Main Authors: De Beer, T.R.M., Vergote, G.J., Baeyens, W.R.G., Remon, J.P., Vervaet, C., Verpoort, F.
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier B.V 01.12.2004; Elsevier
• Subjects: Biological and medical sciences; Chromatography, High Pressure Liquid; FT-Raman spectroscopy; General pharmacology; HPLC; Medical sciences; Medroxyprogesterone Acetate - analysis; Medroxyprogesterone Acetate - standards; Models, Chemical; Pharmaceutical Solutions - analysis; Pharmaceutical Solutions - standards; Pharmaceutical suspension; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Spectrum Analysis, Raman - methods; Spectrum Analysis, Raman - standards; Technology, Pharmaceutical - methods; Validation; Validation; FT-Raman spectroscopy; Pharmaceutical suspension; HPLC; Pharmaceutical technology; Dosage form; HPLC chromatography; Medroxyprogesterone; Suspension; Acetate; Quantitative analysis; Progestagen

A simple linear regression method was developed and statistically validated for the direct and non-destructive quantitative analysis—without sample preparation—of the active pharmaceutical ingredient (API) medroxyprogesterone acetate (MPA) in an aqueous pharmaceutical suspension (150 mg in 1.0 ml) u...