SAXAGLIPTIN LEVELS AND ITS PHARMACOKINETIC APPLICATION IN PRESENCE OF SUCRALOSE IN ANIMALS SERUM BY HPLC METHOD

Objective: It is to develop a simple, valid and rapid chromatographic method for quantification of saxagliptin in rats serum in order to study saxagliptin pharmacokinetics parameters in sucralose fed rats simultaneously to detect any interaction possibility between saxagliptin and sucralose in rats. Methods: In our developed method of analysis, mobile phase was consisted of phosphate buffer (pH =4) and methanol (70:30) v/v at flow rate of 1 ml/min with UV detection at 230 nm., C8 column of separation was used with the temperature of 40 °C using injection volume of 50 µl, samples run time was 10 min, and sildenafil citrate was used as internal standard. Saxagliptin was given to rats orally of (2g/kg) dose while sucralose was given with (11 mg/kg/day) dose. Results: A successful HPLC method was validated and developed to determine saxagliptin in rats serum, overall intra-day precision and accuracy were reasonable with coefficient of variation percentage CV % values range (o.14-4.03) and accuracy % range (99.5-104), while inter-day precision and accuracy showed accepted precision with CV% range (0.15-2.81) and accuracy % range (99.9-116). The coefficient of correlation was 0.99949 with reasonable sensitivity and selectivity. Combination effect of saxagliptin with sucralose on saxagliptin serum profile was demonstrated as strong statistical effect according to Cohen’s d and significant P values too. Conclusion: A successful HPLC method was validated and developed to quantify saxagliptin in rats serum, combination effect of saxagliptin with sucralose over all time intervals of saxagliptin serum profile was demonstrated as strong statistical effect.