ESTIMATION OF PERINDOPRIL ARGININE, INDAPAMIDE AND AMLODIPINE IN BULK AND FIXED DOSE COMBINATION USING STABILITY INDICATING REVERSE PHASE HIGH-PRESSURE LIQUID CHROMATOGRAPHYAbstract
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 wavelength 215 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 ± 0.41 min, and 36.95 ± 0.47 min, respectively. The method was linear over the concen-tration 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 was 3.02 µg/ mL for Perindopril, 2.6 µg/ mL for Indapamide and 12.08 µg/ mL for Amlodipine. Under forced degradation conditions, Perindopril degraded signi-ficantly under acidic, alkaline, oxidative, and thermal stress conditions degraded moderately under photolytic stress conditions and degraded the least under neutral conditions. Indapamide degraded significantly under acidic, alkaline, and oxidative stress conditions; degraded moderately under the neutral condition and degraded the least under thermal and photolytic stress conditions. Amlodipine degraded significantly under acidic, alkaline and oxidative stress conditions, degraded moderately under photolytic stress conditions and showed negligible degradation under neutral conditions.