ANALISIS UJI DISOLUSI TABLET GLIBENKLAMID BERMERK DAN GENERIK DENGAN METODE SPEKTROFOTOMETRI UV-VIS

Glibenklamid adalah obat yang digunakan untuk DM tipe 2 golongan sulfonil urea, seperti halnya obat yang lain glibenklamid juga terdapat dalam bentuk obat generik dan bermerk. Banyak masyarakat yang masih berasumsi bahwa obat generik dan bermerk mempunyai zat aktif yang berbeda. Penelitian ini bertujuan untuk mengetahui kadar glibenklamid generik dan bermerk yang diuji disolusi menggunakan Spektrofotometri UV-Vis. Penelitian ini dilakukan penetapan kadar menggunakan Spektrofotometri UV-Vis Shimadzu dengan pelarut HCl-Metanol 0,1 N pada gelombang 300 nm. Pembuaan kurva baku konsenrasi 40, 50, 60, 70 dan 80 ppm. Validasi meliputi linearitas, presisi, akurasi LOD dan LOQ dilakukan pada glibenklamid baku. Table generik dan bermerk dilakukan penetapan kadar pada panjang gelombang maksimum yang ditenukan lalu dilakukan uji disolusi menggunakan pelarut asam klorida 0,1 N dengan suhu 37ºC ± 0,5ºC dengan menggunakan metode dayung. Hasil validasi glibenklamid baku linearitas (0,9989), presisi (0,37%), akurasi (82%), LOD (57,173 ppm) dan LOQ (173,250 ppm). Kadar glibenklamid dalam tablet generik 1, generik 2, bermerk 1 dan bermerk 2 berturut-turut 63%, 97%, 106% dan 91%. Hasil uji disolusi kurang bagus dikarenakan pelarut yang digunakan berbeda sehingga menghasilkan nilai absorbansi minus dan tidak dapat dilakukan uji SPSS. Glibenclamide is a drug used for type 2 DM of the sulfonyl group of urea, as well as other drugs, glibenclamide is also found in generic and branded drug form. Many people still assume that generic and branded drugs have different active substances. This study aims to determine the levels of generic and branded glibenclamide that are tested and resolved using UV-Vis Spectrophotometry. This study was carried out to determine the level using UV-Vis Shimadzu Spectrophotometry with 0.1 N HCl-Methanol solvent at 300 nm wave. The standard concentration curve is 40, 50, 60, 70 and 80 ppm. Validation including linearity, precision, LOD and LOQ accuracy was performed on the raw glibenclamide. Generic and branded tables were determined at the maximum wavelength that was determined, then a solution test was carried out using a 0.1 N hydrochloric acid solvent with a temperature of 37ºC ± 0.5ºC using the paddle method. The results of the validation of standard glibenclamide linearity (0.9989), precision (0.37%), accuracy (82%), LOD (57.173 ppm) and LOQ (173.250 ppm). The levels of glibenclamide in generic 1, generic 2, branded 1 and branded 2 tablets were 63%, 97%, 106% and 91% respectively. The results of the test were not good because the solvents used were different so that they produced a minus absorbance value and the SPSS test could not be carried out.