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JURNAL SAINS NATURAL Pub Date : 2019-12-14 DOI:10.31938/JSN.V6I1.249

Syahruni Syahruni, D. Arrisujaya

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引用次数: 0

摘要

原料药含量是保证制剂质量必须满足的要求，进行原料药含量的测定需要经过验证的方法。对500 mg甲氧胺酸包衣片(商品名)的含量测定方法进行了验证。甲法那酸的测定方法采用紫外分光光度法，使有限的可用工具可以高效液相色谱法进行解析。用标准加法法的精度参数和参数精度参数来检验替代方法的有效性。根据所得结果，其线性值为r = 0,999，分光光度法与高效液相色谱法的百分比差(%差)为0,16%。结果表明，采用分光光度法测定泊胺甲胺酸500 mg薄膜包衣片(商品名)的含量，符合ISO / IEC 17025的要求。【关键词】甲氨酰胺酸;验证方法;紫外分光光度法;方法的有效性替代penetapan kadar asam mefenamamalam ponsam500 mg片剂salut selaput (nama dagang) telah dilakukan。方法:用紫外分光光度法、紫外分光光度法、高效液相色谱法、紫外分光光度法、紫外分光光度法、紫外分光光度法、紫外分光光度法等。有效性方法替代diuji berdasarkan参数akurasi dengan方法penambahan baku dan参数ketelitian。Berdasarkan hasil - diperololi - linitas alalali - sebesar = 0,999, perbedaan - perbedaan - metoftem - dengan - HPLC (% Difference) = 0,16%。Hasil penelitian menunjukkan方法替代penelitian menunjukkan方法，该方法可替代penelitian menunjukkan方法，该方法可替代penelitian menunjukkan方法(nama dagang)。Kata kunci: Asam mefenamat, Validasi方法，分光光度仪UV

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

Alternative of analytical methods of assay mefenamic acid in posamic 500 mg film coated tabletThe 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 spectrophotometryABSTRAK 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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JURNAL SAINS NATURAL

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