<![CDATA[INTISARI Kombinasi klorfeniramin maleat (CTM) dan guaifenesin (GG) digunakan untuk meringankan gejala batuk dan pilek. Kadar CTM dan GG dalam sirup sangat kecil sehingga penetapan kadarnya memerlukan metode yang valid. Tujuan penelitian ini adalah memvalidasi metode penetapan kadar CTM dan GG dan mengaplikasikannya dalam beberapa sediaan sirup di pasaran. Penetapankadar CTM dan GG menggunakan KCKTJascoLc-Net II/ADC dengandetektor UV-Visible. Fase diam berupa C18Li Chospher dan fase gerak adalah campuran asetonitril:metanol:air (15:10:75 v/v), waktu alir 1 mL/menit pada panjang gelombang 270 nm. Validasi metode meliputi akurasi, presisi, selektivitas, linieritas dan sensitivitas. Metode analisis diaplikasikan terhadap 3 merk sirup dari pabrik yang berbeda. Hasil penelitian menunjukkan bahwa validasi metode penetapan kadar CTM dan GG memenuhi persyaratan yaitu: uji presisi menghasilkan %RSD untuk CTM 0,18% dan GG 0,17%;ujiakurasi menghasilkan perolehan kembali yang memenuhi persyaratan baikuntuk CTM maupun GG pada sirup ketigamerksirup. Selektivitasnya baik; linieritas memenuhi syarat; LOD CTM dan GG masing masing sebesar 2,40 µg/mL dan 3,07 µg/mL; LOQ CTM dan GG masing-masing sebesar 8,00 µg/mL dan 10,24 µg/mL. Kadar rata-rata CTM dan GG pada ketiga sirup memenuhi persyaratan kadar yang ditetapkan oleh Farmakope Indonesia Edisi V. Kata kunci : validasi, klorfeniramin maleat, guaifenesin, KCKT ABSTRACT The combination of CTM and GG is often used as an active substances to relieve symptoms of cough and cold. The concentration of CTM and GG in syrup are very low, so that it need validated determination method to ensure therapeutic dose. The purposes of this study were to validate determination method of CTM and GG and to apply the method to some syrups. Determination of CTM and GG in syrup using HPLC JascoLc-Net II/ADC equipped with a UV-Visible detector at a wavelength of 270 nm. The stationary phase used was C18Li Chosphera nd the mobile phase usedwas a mixture of acetonitrile:methanol:water (15:10:75 v/v) with a flow rate of 1 mL/minutes.Validation test was conducted on precision test, accuracy, selectivity, linearity and sensitivity. The method of analysis was applied to syrups fromthree different factories. The result of this research showed that validation tests of CTM and GG met the requirements, were: % RSD of precision test for CTM was 0.18% and for GG was 0.17%; accuracy test resulted good recovery for CTM and for GG in syrups. Good selectivity; linearity with a correlation coefficient 0.999; LOD for CTM and GG were 2.40 and 3.07 µg/mL; LOQ for CTM and GG were 8.00µg/mL and 10.24 µg/mL. The level of CTM and GG in syrups were compliance with the requirements by the Indonesian Pharmacopeia Edition V. Keywords: validation, chlorfeniramin maleat, guaifenesin, HPLC]]>
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