Research Article

Validated Stability Indicating HPTLC Method for the Determination of Dutasteride in Pharmaceutical Dosage Forms

Table 2

Summary of degradation products of DUTA under different stress conditions.

Stress conditions 𝑅 𝑓 values of degradation productsPeak purity data 𝑟 ( 𝑆 , 𝑀 ) , 𝑟 ( 𝑀 , 𝐸 )

Acid hydrolysis, 0.1 N HCl, refluxed for 8 h at 50°C0.550.9991, 0.9996
Alkaline hydrolysis, 1 N NaOH, refluxed for 4 h at 50°C0.26, 0.550.9998, 0.9994
Oxidation (H2O2, 30% v/v), refluxed for 3 h at 50°C0.39, 0.550.9996, 0.9995
Wet heat, refluxed for 10 h at 100°C0.550.9993, 0.9996
Dry heat, heated in oven at 100°C for 24 hNot detected0.9990, 0.9994
Day light, exposed to sunlight for 48 hNot detected0.9993, 0.9996
UV light, exposed to UV light (254 nm) for 48 hNot detected0.9995, 0.9997