Abstract

DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR STIMULTANEUS ESTIMATION OF REMOGLIFLOZIN ETABONATE AND TENELIGLIPTIN IN PHARMACEUTICAL DOSAGE FORM

Vashi Dhara* and Gamit Dharmistha

ABSTRACT

A simple, sensitive, precise, specific and accurate Reversed phase high performance liquid Chromatographic (RP-HPLC) method has been developed and validated for estimation of Remogliflozin Etabonate and Teneligliptin in Pharmaceutical dosage form. Chromatographic method was conducted on Isocratic mode technique on a Reversed-Phase Cosmosil C18 (250 mm × 4.6 mm, 5μm i.d.) column. Detection wavelength was 245 nm and mobile phase Acetonitrile: Water [80:20 %w/v] used for simultaneous estimation of Remogliflozin Etabonate and Teneligliptin. The flow rate was used 1.0 ml/min and retention times for both drugs are 2.4 min and 3.5 min, respectively. the method was shown to be linear over the concentration rage 10-80 μg/ml for Remogliflozin Etabonate and 1-8 μg/ml for Teneligliptin. The r2 values was found to be 0.9992 and 0.9997 for Remogliflozin Etabonate and teneligliptin, respectively. LOD was found to be 0.092 μg/ml and 0.279 μg/ml and LOQ was found to be 0.147 μg/ml and 0.446 μg/ml, for Remogliflozin Etabonate and Teneligliptin, respectively. The accuracy of the method was assessed by adding fixed amount of different standard solutions (80%, 100% and 200% of the tested concentration) in triplicate. The percentage mean recoveries were 99.15-99.49 % for Remogliflozin Etabonate and 99.44-100.50 % for Teneligliptin, respectively. The method specificity and robustness were also established. A new and sensitive high performance liquid Chromatographic method was developed for simultaneous estimation of Remogliflozin Etabonate and Teneligliptin in pharmaceutical dosage form and validated as per ICH Q2 (R1) guideline.

Keywords: Teneligliptin, Remogliflozin Etabonate, Simultaneous Estimation, Method Development, Validation.