Study of stability elaboration cream Сlotrikarb
Abstract
Study the establishment of stability and shelf-life of the drug (HP) is one of the important tasks of pharmaceutical development. When a new drug shelf-life is determined experimentally by periodic assessment of quality indicators laid down in the specification. It is advisable to study the stability of the developed soft drugs in a container, which is more commonly used in the industry - tubes and pharmacy manufacturing - plastic containers.
The aim of this study was to investigate the stability of the developed creams and determine its expiration date.
The object of the study was designed PM Clotrikarb – cream based on an emulsion of the oil / water containing clotrimazole (1%) and urea (5%). Samples PM stored at different temperatures, according to the Ukrainian State Pharmacopoeia (HFCs).
The quality of drugs during storage was evaluated organoleptic physico-chemical and microbiological analysis methods according to the recommendations of HFCs. Identification and quantitative content of clotrimazole was performed by HPLC on Agilent 1200 chromatograph with diode array detector (USA). Identification of urea was determined by reaction of color, and quantitative content – by titrometry (HFCs). Structural and mechanical properties were studied on a rotary viscometer Reotest-2 (US) with a circulating water heater.
Analysis of the data indicates that the MLA samples, which were stored under different conditions, the tests were kept on all counts specification. The quantitative content of active ingredients in the cream is developed within the permissible limits. Microbiological studies have shown that during the entire shelf life of the cream Clotrikarb meets HFCs. Total number of aerobic microorganisms (TAMC) is less than 50 cfu/g; the total number of yeasts and molds (TYMC) – less than 10 CFU/g; it revealed no Staphylococcus aureus and Pseudomonas aeruginosa in 1 g of the drug. Rheological studies cream confirm their satisfactory consumer properties.
Experimental studies confirmed the stability of the cream Klotrikarb during storage and determine the recommended shelf life of the product – 2 years at a temperature no higher than 25 °C.
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