Keywords:Pioglitazone, Teneligliptin, RP- HPLC, Validation, ICH Guidelines

ABSTRACT

The present study was aimed at the development of analytical method for the estimation of Pioglitazone and Teneligliptin in Bulk and Combined Dosage Form using RP-HPLC. The analysis was performed with a Kromasil C18 column (250×4.6 mm, 5 μm) at 30°C using water: methanol (50:50 v/v) as mobile phase. The detection was carried out with a flow rate of 1.0 mL/min at 254 nm. The method was validated as per the ICH Guidelines. The various parameters tested included accuracy, precision, specificity, limit of detection, limit of quantitation and robustness. The retention time of teneligliptin and metformin was 2.842 min and 2.017 min, respectively. The linearity range was 3-15 μg/mL for metformin and 5-30 μg/mL for teneligliptin. The percentage recovery was found to be 99.381- 99.884% for Pioglitazone and 98.649-99.647% respectively. The LOD and LOQ were found to be 0.129μg/ml and 0.389μg/ml for Pioglitazone and 0.106μg/ml and 0.323μg/ml respectively. Robustness was less than 2% which is as per the acceptance criteria of ICH Guidelines. Percentage assay was found to be 100.66 ± 1.234 for Pioglitazone and 101.35± 1.587 for Teneligliptin. The developed method is simple, accurate, specific, précised, reproducible and the validation results obtained for the method were as per the acceptance criteria of the ICH Guidelines. Hence the developed method could be used for the regular estimation of Pioglitazone and Teneligliptin in Bulk and Combined Dosage Form.