Stability Indicating RP-HPLC Method Development and Validation for Oseltamivir API

• Published in: Chemical & Pharmaceutical Bulletin Vol. 56; no. 4; pp. 413 - 417
• Main Authors: Narasimhan, Balasubramanian, Abida, Khan, Srinivas, Kona
• Format: Journal Article
• Language: English; Japanese
• Published: Japan The Pharmaceutical Society of Japan 01.04.2008; Pharmaceutical Society of Japan; Japan Science and Technology Agency
• Subjects: Chromatography, High Pressure Liquid; Drug Stability; forced degradation; Hydrogen-Ion Concentration; Indicators and Reagents; oseltamivir; Oseltamivir - analysis; Oxidation-Reduction; Reference Standards; Reproducibility of Results; reverse-phase-HPLC; Spectrophotometry, Ultraviolet; stability indicating assay
• ISSN: 0009-2363; 1347-5223
• DOI: 10.1248/cpb.56.413

The present study describes the development and subsequent validation of a stability indicating reverse-phase HPLC (RP-HPLC) method for the analysis of oseltamivir active pharmaceutical ingredient (API). The proposed RP-HPLC method utilizes Kromasil C18, 5 μm, 250 mm×4.6 mm i.d. column (at ambient temperature), gradient run (using acetonitrile and triethylamine as mobile phase), effluent flow rate (1.0 ml/min), and UV detection at 215 nm for analysis of oseltamivir. The described method was linear over the range of 70—130 μg/ml (r2=0.999). The precision, ruggedness and robustness values were also within the prescribed limits (<1% for system precision and <2% for other parameters). Oseltamivir was exposed to acidic, basic, oxidative and thermal stress conditions, and the stressed samples were analyzed by the proposed method. Chromatographic peak purity results indicated the absence of co-eluting peaks with the main peak of oseltamivir, which demonstrated the specificity of assay method for estimation of oseltamivir in presence of degradation products. The proposed method can be used for routine analysis of oseltamivir in quality control laboratories.