Development and Validation of a Stability Indicating Rp-hplc Method for Simultaneous Estimation of Teneligliptin and Remogliflozin Etabonate in Bulk and Tablet Dosage Form
Year: 2025
Type: article
Abstract: For the simultaneous quantitation of Remogliflozin Etabonate (REM) and Teneligliptin (TEN) in bulk and dosage form, a unique, accurate, reliable, and selective stability demonstrating RP-HPLC method was designed and validated.To verify the approach's stability demonstrating characteristics, the drugs were treated to a range of environments (alkaline, thermal, photolytic, acid and oxidative).To accomplish an isocratic separation of proposed drugs, a PDA detection system at 235 nm and a Thermo BDS Hypersil C18 column (150 × 4.6 mm, 5 μm) were used.Acetonitrile : Water (50:50 v/v) was employed as eluent and forced at 1 mL/min.The approach had used 20 µL injection volume and column temperature was kept at 25°C.The retention time for drugs (REM and TEN) were 3.7 min and 7.0 min correspondingly.The approach showed linearity from 80-240 µg/mL having R² = 0.9999 for REM and 8-24 µg/mL having R² = 0.9999 for TEN.The % RSD was discovered to be less than 2 %.The percent recovery was discovered to be between 98% and 102%.REM was more susceptible to degrade in acidic, thermal and photolytic environments.TEN also showed degradation in alkaline, acidic and photolytic
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
Funder: Glenmark Pharmaceuticals
OpenAlex ID: W4413840312