UJI STABILITAS KIMIASEDIAAN PULVERES KLORFENIRAMIN MALEAT YANG DIRACIK DI PUSKESMAS NGEMPLAK 2 KABUPATEN SLEMAN DAERAH ISTIMEWAYOGYAKARTA

Abstract

Currently,compounded pulveres drug can be used as a solution to the problem when the products from the factory do not meet the needs of patients in treatment therapy. The important thing to maintain the efficacy of the compounded of pulveres preparations is the stability of the drug. One of the factors that can influence the stability of pulveres is the interaction between the drug and the environment during process of compounding the pulveres. The research was conducted to find out the process flow of pulveres preparation and to investige the stability of pulveres Puskesmas Ngemplak 2 at Sleman of Yogyakarta. The design of the study was using cross-sectional observational method with qualitative and quantitative approach. Qualitative test was used to find out the suitability of drug compounding process obtained from observation result at puskesmas, while the quantitative test was using UV Spectrophotometer by validating the method to know the stability of the sample. The compounding process at Puskesmas Ngemplak 2 had been done correctly according to guideline. The uniformity weight of Chlorpheniramine Maleat did not meet the requirements. Which, from 20 pulveres only 12 packets that inside the 10% of range, while the other 8 packets out of 10% range, and 5 packs was out of 15% of range. According to requirements, weight of each package to average weight of each package, from 20 packages not more than 15% for 2 packages and not more than 10% for 18 packages. From the stability test, it was found a decrease level of Chlorpheniramine Maleat, during storage which in the day 0 was 139%, day 3 was 135%, day 6 was 134%, day 9 was 130%, day 12 was 132%, day 15 was 131%. The drug content did not meet Farmacopeia Indonesia V requirement of 93% - 107% of labelled content. According to USP 30, Beyond Use Date of Chlorpheniramine Maleat pulveres which compounded in PuskesmasNgemplak 2 was for 4 months from compounding time.