Determination of alogliptin benzoate and pioglitazone hydrochloride in their dosage forms, validation and stability-indicating studies using RP-HPLC method.

Document Type : Research Articles

Authors

1 Department of analytical chemistry, College of Pharmacy, Al-Azhar University, Cairo, Egypt

2 Pharmaceutical chemistry department, Faculty of Pharmacy, Al-Azhar University, Assiut, Egypt

Abstract

A recent, sensitive, stability-indicating RP-HPLC method was used and applied for the simultaneous quantitation of alogliptin benzoate and pioglitazone hydrochloride in their dosage form. Stability tests were done through application of stress conditions on the analyte's solution. Resolution of the drugs was achieved on BDS C18 Column (250x 4.6 mm) and the mobile phase consisted of sodium phosphate pH 3.6, and acetonitrile (60:40; v/v). The flow rate was 1 ml/min and the detector was set at 271 nm. The analytical method was tested for Linearity, accuracy, specificity, precision, ruggedness and robustness. The described HPLC method is valid for quantitation of alogliptin benzoate and Pioglitazone HCl in Tablets and valid as stability indicating method.

The study concerned with the analytical method described for determination of alogliptin benzoate and Pioglitazone HCl in Tablets. The analytical method was tested for Linearity, accuracy, precision, specificity, ruggedness and robustness.

Key words: HPLC, alogliptin, pioglitazone, Stability tests

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