Study of release kinetics of the active ingredients from the combined tablet Amlopamid
The creation and introduction of domestic combined drugs for the treatment of hypertension is extremely important and a priority within the import substitution program in Ukraine. Test «dissolution» is used to evaluate the release of active pharmaceutical ingredients from solid dosage forms for oral administration. The goal was an experimental study of the release kinetics of active ingredients from the combined antihypertensive tablets Amlopamid both as freshly prepared drug, and tablets after 12 and 27 months of storage at a temperature of 20 ± 5 °C.
The developed samples of tripartite preparation Amlopamid for the treatment of hypertension were subject of this research. Amlodipine besylate, lisinopril dihydrate, indapamide as active pharmaceutical ingredients are included of the composition of the tablets. Using a device with a vane «Erweka» (Germany) the test «dissolution» for solid dosage forms was conducted to investigate the release of active substances from tablets. Quantification of active ingredients of the combined tablets Amlopamid was performed by high performance liquid chromatography.
The results showed that the release of amlodipine besylate, lisinopril dehydrate and indapamide from the tablet during 45 minutes are about 85–95 %, they are corresponded SPU. It was founded the release kinetics of active substance are corresponded SPU during the developed tablets storage for 27 months at a temperature of 20 ± 5 °C; the stability of the developed combined tablets in test «dissolution» are confirmed.
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