Stability indicating RP-HPLC method development and validation for oseltamivir API.
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 C(18), 5 microm, 250 mm x 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 microg/ml (r(2)=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.
Narasimhan
Balasubramanian
B
Department of Pharmaceutical Sciences, Guru Jambheshwar University of Science and Technology, Haryana, India. naru2000us@yahoo.com
Abida
Khan
K
Srinivas
Kona
K
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D053139:Oseltamivir / Q000032:analysis*; D010084:Oxidation-Reduction; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D007202:Indicators and Reagents; D053139:Oseltamivir