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 ?m) were used. Acetonitrile : Water (50:50 v/v) was employed as eluent and forced at 1 mL/min. The approach had used 20 ?L 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 ?g/mL having R² = 0.9999 for REM and 8-24 ?g/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 environment. The proposed methodology was regarded as being robust, linear, reliable, precise and accurate and able to analyse the drugs in tablet. Keywords: RP–HPLC, Validation, Teneligliptin, Forced degradation, Remogliflozin Etabonate, Simultaneous Estimation
Publication date: 01/09/2025

https://ijbpas.com/pdf/2025/September/MS_IJBPAS_2025_8629.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.9.8629