Pharmaceutica Analytica Acta

Abstrait

Pioglitazone HCl Levels and Its Pharmacokinetic Application in Presence of Sucralose in Animals Serum by HPLC Method

Lina Tamimi, Wael Abu Dayyih, Nidal Qinna, Eyad Mallah and Tawfiq Arafat

Purpose: to develop a simple, valid and rapid chromatographic method for quantifying pioglitazone HCl in rats serum in order to study the pharmacokinetic parameters of pioglitazone HCl in rats serum fed with sucralose simultaneously for examination of interaction possibility between pioglitazone HCl and sucralose in rats. Methods: In our developed method of analysis, mobile phase was consisted of [51.50%] acetonitrile and [48.50%] 0.025 mM ammonium acetate with pH of 8, column of separation was C8 at temperature of 40°C using injection volume of 90 μl, mobile phase flow rate was 1 ml/min and samples run time was 10 min, the signals were monitored and analyzed at λ=269 nm and sildenafil citrate was used as internal standard. Pioglitazone was given to rats orally of [10mg/kg] dose while sucralose was given with [11 mg/kg/day] dose. Results: A successful HPLC method was validated and developed to quantify pioglitazone HCl in rats serum, overall intra-day precision and accuracy were reasonable with CV % values range [0.16-3.54] and accuracy % range [ 98.4-107.9], while inter-day precision and accuracy showed accepted precision with CV% range [ 0.15- 4.13] and accuracy % range [99.35-103.99]. The coefficient of correlation was 0.9991 with reasonable sensitivity and selectivity. Combination effect of pioglitazone with sucralose on pioglitazone 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 pioglitazone HCl in rats serum, combination effect of pioglitazone with sucralose over all time intervals of pioglitazone serum profile was demonstrated as strong statistical effect.