Developing and validating of rp-hplc method for simultaneous quantification of indapamide and perindopril tert-butylamine in tablets

Abstract

    Hypertension is the world’s leading cause of death. The number of people with hypertension, particularly at a young age, is constantly increasing. The proportion of patients with uncontrolled hypertension also grows due to ineffective monotherapy. Therefore, the use of fixed-dose combination drugs such as Indapamide (IND – Thiazid-like) and Perindopril tert-butylamine (PER – ACE inhibitor) has become common. However, the Pharmacopoeia from Viet Nam and from other countries do not include specific guidelines on the process of simultaneous quantification of these 2 substances. Thus, this study was conducted to develop and validate the simultaneous quantification process of Indapamide and Perindopril tert-butylamine in tablets by high-performance liquid chromatography (HPLC). A method has been developed for the simultaneous quantification of Indapamide and Perindopril tert-butylamine with mobile phase consisting of acetonitril/0.01 % perchloric acid water (33:67), HiQ sil C18HS column (250 mm × 4.6 mm, 5 μm), column temperature 35 °C, flow rate 1.2 mL/min, injection 10 μl, detecter PDA, and wavelength 215 nm. Sample processing conditions: ethanol extraction, no ultrasonication. The method has been validated according to the ICH guidelines, including: system suitability; specificity; linearity from (5-35) ppm and (10-100) ppm, respectively for Indapamide and Perindopril tert-butylamine (R > 0.9999); the detection limit and the quantitative limit for Indapamide and Perindopril tert-butylamine were 0.59 ppm and 1.79 ppm, and 1.47 ppm and 4.45 ppm respectively; accuracy (recovery rate of  (98.0-102.0) %); precision (RSD < 2.0 %).