The study of stability of the combined antihypertensive tablets during storage
Keywords:combined tablets, amlodipine, indapamide, lisinopril, shelf life, stability
Creation of drugs for treating hypertension, namely the combined tablets based on antihypertensive agents of different pharmacological groups, is very important for domestic pharmaceutical science and practice. According to the results of the previous studies the composition and technology of the combined tablets “Amlopamide” for treating hypertension have been developed. As active ingredients these tablets contain amlodipine besylate, lisinopril dehydrate and indapamide. The excipients are microcrystalline cellulose, lactose monohydrate, potato starch and calcium stearate. The aim of this work was to study the physical and chemical, pharmaceutical and technological parameters, as well as microbiological purity of the combined tablets during storage. The modern methods of testing are used to determine stability of “Amlopamide” tablets obtained by direct compression in accordance with the State Pharmacopoeia of Ukraine. To determine the shelf life of the combined antihypertensive tablets “Amlopamide”, as well as to study their stability, different batches of the drug were kept in different containers at a temperature of (20±5)°C. The control of the drug stability was performed according to all parameters: appearance, the average tablet weight, disintegration time, dissolution, uniformity of dosage units, identification, the assay content of active substances and microbiological purity. The results of the experimental studies have shown that during storage for 27 months at a temperature of (20±5)ºC the samples of the combined tablets “Amlopamide” in all containers used by all parameters meet the requirements of normative documents and State Pharmacopoeia of Ukraine (SPhU). It has been determined that the shelf life of the tablets is 2 years while storing at room temperature.
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