ALTERNATIF METODE ANALISIS PENETAPAN KADAR ASAM MEFENAMAT DALAM PONSAMIC 500 mg TABLET SALUT SELAPUT

Syahruni Syahruni, Dian Arrisujaya

Abstract


Alternative of analytical methods of assay mefenamic acid in posamic 500 mg film coated tablet

The level of active substance is a requirement that must be met to ensure the quality of medicinal preparations, to carry out the assay of the active drug substance required a method that has been validated. The validity of alternative methods of assay in ponsamic mefenamic acid 500 mg film coated tablet (trade name) has been performed. Mefanat acid assay method using UV spectrophotometry, so that the limited availability of tools that can be resolved HPLC. The validity of alternative methods tested by the parameters of accuracy with standard addition method and parameters accuracy. Based on the results obtained by the value of the linearity was r equal to 0,999 and the percentage difference spectrophotometric method with HPLC method (% difference) at 0,16%. The results showed an alternative method of assay in ponsamic mefenamic acid 500 mg film coated tablet (trade name) using spectrophotometric methods, qualified acceptance in accordance with ISO / IEC 17025.

Keywords: Mefenamic acid, validation method, UV spectrophotometry

ABSTRAK 

Pemeriksaan kadar zat aktif merupakan persyaratan yang harus dipenuhi untuk menjamin kualitas sediaan obat, untuk melakukan penetapan kadar zat aktif obat dibutuhkan suatu metode yang telah divalidasi. Validitas metode alternatif penetapan kadar asam mefenamat dalam ponsamic 500 mg tablet salut selaput (nama dagang) telah dilakukan. Metode penentuan kadar asam mefanat menggunakan spektrofotometri UV, sehingga ketersediaan alat HPLC yang terbatas dapat teratasi. Validitas metode alternatif diuji berdasarkan parameter akurasi dengan metode penambahan baku dan parameter ketelitian. Berdasarkan hasil diperoleh nilai linearitas adalah r sebesar 0,999 dan  persentase perbedaan metode spektrofotometri dengan metode HPLC (% Difference) sebesar 0,16%. Hasil penelitian menunjukkan metode alternatif penetapan kadar asam mefenamat dalam ponsamic 500 mg tablet salut selaput (nama dagang) menggunakan metode spektrofotometri, memenuhi syarat untuk diterima sesuai ISO/IEC 17025.

Kata kunci : Asam mefenamat, Validasi metode, Spektrofotometri UV

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References


Chan, C. C. 2004. Analytical Method Validationand Instrumental Performent Verification. Willey Intercine A. John Willy and Sons. Inc., Publication.

Dirjen POM. 1995. Farmakope Indonesia Edisi IV. Departemen Kesehatan RI. Jakarta.

Hairani D. 2007. Pelatihan Sertifikasi Nasional Kompetensi Apoteker. Jakarta.

Harmita. 2004. Petunjuk Pelaksananaan Validasi Metoda dan Cara Perhitungan. Majalah Ilmu Kefarmasian. 1 (3): 117-135.

[ICH] International Conference on Harmonization. 1995. Validation of analytical procedures: Text and Methodology Q2(R1).

Munaf, S. 1994. Catatan Kuliah Farmakologi Bagian II. Penerbit Buku Kedokteran EGC. Jakarta.

Priyambodo, B. 2014. Validasi Metode Analisa. https://priyambodo 1971 .wordpress.com/cpob/kualifikasi-dan-validasi-paradigma-baru/ validasi-metode-analisa-vma/ comment-page-1/.diakses 20 Desember 2016

Riyanto. 2014. Validasi Dan Verifikasi Metode Uji Sesuai dengan ISO/IEC 17025. Laboratorium Pengujian dan Kalibrasi. Yogyakarta.

Sitorus. 2001. Pedoman Cara Pembuatan Obat yang Baik. Badan Pengawas Obat dan Makanan. Jakarta.

Tetrasari. 2003. Validasi Metode Analisis. Pusat Pengkajian Obat dan Makanan BPPOM.




DOI: https://doi.org/10.31938/jsn.v6i1.249

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