Validasi Metode Analisis Untuk Penetapan Kadar Tablet Asam Mefenamat Secara Spektrofotometri Ultraviolet

VALIDASI METODE ANALISIS UNTUK PENETAPAN KADAR TABLET ASAM MEFENAMAT SECARA SPEKTROFOTOMETRI ULTRAVIOLET Noviny Ramayany Uno1), Sri Sudewi1), Widya Astuty Lolo1) 1)Program Studi Farmasi FMIPA UNSRAT Manado, 95115 ABSTRACT The level of active substance is a requirement that must be met to ensure the quality of drugs, to make the determination of drug levels is needed a method that has been validated. This study aims to determine the validity and the levels of mefenamic acid in tablet dosage using UV spectrophotometry and determine the suitability of levels tablet mefenamic acid with trade name and generic with the requirement levels according to the Indonesian Pharmacopoeia fourth edition (1995). Its validity were tested based on the parameters of accuracy used standard addition method and precision parameters. Based on the results the linearity value was obtain r = 0.9979 with limits of detection (LOD) is 0.1246 ppm and limits of quantitation (LOQ) is 0.4154 ppm. The results showed levels of mefenamic acid in tablet dosage trade name (1) is 11.3580 ± 0.6344 ppm, trade names (2) is 11.3044 ± 0.4147 ppm, generic (1) is 11.3044 ± 0, 5664 ppm, generic (2) was 11.604 ± 0.4180 ppm. It showed mefenamic acid levels in tablet dosage generic and trade names fulfill level requirements contained in the Indonesian Pharmacopoeia fourth edition (1995). Keywords: Mefenamic acid, Method validation, UV spectrophotometry ABSTRAK Pemeriksaan kadar zat aktif merupakan persyaratan yang harus dipenuhi untuk menjamin kualitas sediaan obat, untuk melakukan penetapan kadar obat dibutuhkan suatu metode yang telah divalidasi. Penelitian ini bertujuan untuk menentukan validitas dan menentukan kadar asam mefenamat dalam sediaan tablet menggunakan metode spektrofotometri UV serta mengetahui kesesuaian kadar tablet asam mefenamat nama dagang dan generik dengan persyaratan kadar menurut Farmakope Indonesia Edisi IV (1995). Validitasnya diuji berdasarkan parameter akurasi dengan metode penambahan baku dan parameter ketelitian. Berdasarkan hasil diperoleh nilai linearitas sebesar r = 0,9979 dengan batas deteksi (LOD) 0,1246 ppm dan (LOQ) 0,4154 ppm. Hasil penelitian menunjukkan kadar asam mefenamat dalam sediaan tablet nama dagang (1) adalah 11,3580 ± 0,6344 ppm, nama dagang (2) adalah 11,3044 ± 0,4147 ppm, generik (1) adalah 11,3044 ± 0,5664 ppm, generik (2) adalah 11,604 ± 0,4180 ppm. Ini menunjukkan kadar asam mefenamat dalam sediaan tablet generik maupun nama dagang memenuhi persyaratan kadar yang tertera dalam Farmakope Indonesia Edisi IV (1995)