STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR RELATED SUBSTANCES OF TESTOSTERONE UNDECANOATE IN CAPSULE DOSAGE FORM

Bairam Ravindar*, Arshiya Nazneen and Manjunath S. Y.

ABSTRACT

Simple RS method is developed and validated as reversed-phase chromatographic method for the identification and quantification of the Testosterone undecanoate related substances. The chromatographic separation was optimized with the Inertsil-ODS-3 C18, 4.6 mm x 250 mm, 5μm. A gradient elution was involved with the Acetonitrile and Water (95:5). The flow rate of the mobile phase and the column temperature was set as 1.5 mL min-1 and 25°C. The detection wave length was optimized at 240 nm, 20μL Capsule volume. A mixture of Water and Acetonitrile 5:95 v/v was used as diluent, and same diluent used for needle wash purpose also. The method is validated as per the ICH guidelines. There should not be any interference of blank and placebo peaks at the Retention Time of the main analyte and its impurities. Intermediate Precision is 0.8. LOD and LOQ are 0.03 and 0.10 PPM. The correlation coefficient is NLT 0.99. No deliberate change in Peak area with a slight change in Wavelength, Flowrate, Column Temp. & Gradient variationRS method for related substances in Testosterone undecanoate is found specific, linear, accurate, precise, rugged and robust hence the validated method is suitable to identify the related substances in Testosterone undecanoate drug.

Keywords: Rp-Hplc, Method Development, And Validation, Related Substances, Testosterone Undecanoate.