ESTIMATION OF PERINDOPRIL ARGININE, INDAPAMIDE AND AMLODIPINE BY HPLC.

      Аннотация: A simple, accurate, and precise stability-indicating reverse phase high pressure liquid chromatographic method was developed and validated for the estimation of Perindopril arginine, Indapamide, and Amlodipine in the bulk and pharmaceutical dosage form. Chromatographic separation was carried out on ZORBAX RX C8 (250 mm × 4.6 mm, 5 µm) as a stationary phase with a mobile phase of gradient system of Phosphate Buffer with pH 2 containing Decane Sulphonate as ion-pairing agent (A) and Acetonitrile (B) at detection wavelength215 nm with flow rate 1.0 mL/min at column temperature 40 ºC. The tR of Perindopril, Indapamide, and Amlodipine was 31.39 ± 0.21 min, 25.73 ± 0.41min, and 36.95 ± 0.47 min, respectively. The method was linear over the concentration ranges 50-150 µg/ mL for Perindopril, 12.5-37.5 µg/ mL for Indapamide and 50-150 µg/ mL for Amlodipine. The LOD was 0.99 µg/ mL for Perindopril,0.87 µg/ mL for Indapamide and 3.99 µg/ mL for Amlodipine. The LOQ was3.02 µg/ mL for Perindopril, 2.6 µg/ mL for Indapamide and 12.08 µg/ mL for Amlodipine.

Ключевые слова: Perindopril arginine, Indapamide, Amlodipine, Reverse phase ion-pair liquid chromatography, Stability indicating assay method, Fixed-dose combination, Validation (ICH Q2 R1)