VALIDASI METODE ANALISIS UNTUK PENETAPAN KADAR TABLET ASAM MEFENAMAT SECARA SPEKTROFOTOMETRI ULTRAVIOLET
DOI:
https://doi.org/10.35799/pha.4.2015.10204Abstract
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).
Kata kunci :Â Asam mefenamat, Validasi metode, Spektrofotometri UV
Â
Downloads
Published
How to Cite
Issue
Section
License
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access)
