Pengembangan Metode Penetapan Kadar Sediaan Kombinasi Antiflu dan Antitusif Dalam Sediaan Farmasi Secara Spektrofotometri Ultraviolet

Abstract

Various antiflu and antitusif drugs available on the market are a combination of two or more active substances in one preparation, one of which is a combination of dextromethorphan HBr (DMP), doxylamine succinate (DOKS) and pseudoephedrine HCl (PSEU). In quality control of drug determination of efficacious substances in drug preparations is an important part need a reliable analysis method and tools and operational costs that are relatively cheaper, easy to implement, but can provide results with good accuracy and precision. The ultraviolet spectrum of dextromethorphan HBr has a maximum wavelength of 278 nm, doxylamine succinate 261 nm, pseudoephedrine HCl 257 nm. The simultaneous determination of DMP, DOKS and PSEU by classical ultraviolet spectrophotometry is difficult because of the adjacent wavelengths. The development of the ultraviolet spectrophotometric method, including the absorption factor method, area under curve and double divisor ratio spectra derivative, has been carried out on various types of preparations.. This study aims to develop ultraviolet spectrophotometry with absorption factor method, area under curve and double divisor ratio spectra derivative to determine the levels of DMP, DOKS and PSEU in tablet and syrup preparations simultaneously. The research was carried out by optimizing the type of solvent namely ethanol, methanol and HCl 0.1 N. Spectrophotometry method of absorption factor, area under curve and double divisor ratio spectra derivative technique then tested its validity based on validation parameter that is liniearitas, accuracy, precision, LOD and LOQ. The method was applied to determine the levels of DMP, DOKS and PSEU in tablet and syrup preparations. The results showed that ethanol was the best solvent for analysis. The application of absorption factor for content determination is carried out at λ1 287 nm, λ2 277 nm, λ3 258 nm for DMP, DOKS, PSEU, respectively. area under curve for content determination is carried out at λ 273-283 nm, λ 262-272 nm, λ 251-261 nm for DMP, DOKS, PSEU, respectively, double divisor ratio spectra derivative technique for content determination is carried out on fisrt derivative at Δλ 2, λ277.0 nm, λ 243.0 nm and 243.2 nm, respectively. From the method validation, we obtain that the results of recovery fulfill the requirements. Based on the results, it can be concluded that the absorption factor, area under curve, double divisor ratio spectra derivative method by ultraviolet spectrophotometry can be used to determine the levels of DMP, DOKS and PSEU in tablet and syrup preparations and fulfill validation requirements.

Berbagai sediaan obat antiflu dan antitusif yang terdapat di pasaran merupakan kombinasi dari dua atau lebih zat aktif dalam satu sediaan salah satunya adalah kombinasi dekstrometorfan HBr (DMP), doksilamin suksinat (DOKS) dan pseudoefedrin HCl (PSEU). Pada pemeriksaan mutu sediaan obat, penetapan kadar zat berkhasiat merupakan bagian yang penting sehingga diperlukan metode analisis yang handal serta alat dan biaya operasional yang relatif lebih murah, mudah dalam pelaksanaannya, tetapi dapat memberikan hasil dengan akurasi dan presisi yang baik. Spektrum ultraviolet DMP mempunyai panjang gelombang maksimal 278 nm, DOKS 261 nm dan PSEU 257 nm. Penetapan kadar DMP, DOKS dan PSEU secara simultan secara spektrofotometri ultraviolet klasik sulit dilakukan karena panjang gelombang berdekatan. Pengembangan metode spektrofotometri ultraviolet antara lain dengan metode absorption factor, area under curve dan double divisor ratio spectra derivative telah dilakukan pada berbagai jenis sediaan. Penelitian ini bertujuan untuk mengembangkan spektrofotometri ultraviolet dengan metode absorption factor, area under curve dan double divisor ratio spectra derivative untuk menetapkan kadar DMP, DOKS dan PSEU pada sediaan tablet dan sirup secara simultan. Penelitian dilakukan dengan mengoptimasi jenis pelarut yaitu etanol, metanol dan HCl 0,1 N. Metode spektrofotometri ultraviolet secara absorption factor, area under curve dan double divisor ratio spectra derivative kemudian diuji validitasnya berdasarkan parameter validasi yaitu linearitas, akurasi, presisi, LOD dan LOQ. Metode diaplikasikan untuk menetapkan kadar DMP, DOKS dan PSEU pada sediaan tablet dan sirup. Hasil penelitian menunjukkan bahwa etanol merupakan pelarut yang terbaik untuk analisis. Aplikasi metode absorption factor penetapan kadar dilakukan pada λ1 287 nm, λ2 277 nm, λ3 258 nm secara berurutan untuk DMP, DOX, dan PSEU, metode area under curve penetapan kadar dilakukan pada λ 273-283 nm, λ 262-272 nm, λ 251-261 nm secara berurutan untuk DMP, DOKS, dan PSEU, metode double divisor ratio spectra derivative penetapan kadar dilakukan pada derivat 1 pada Δλ 2, λ 277,0 nm, λ 243,0 nm dan 243,2 nm, secara berurutan untuk DMP, DOKS, dan PSEU. Validasi metode yang dilakukan didapat hasil perolehan kembali yang memenuhi persyaratan. Berdasarkan hasil penelitian, maka dapat disimpulkan bahwa metode absorption factor, area under curve, double divisor ratio spectra derivative secara spektrofotometri ultraviolet dapat digunakan untuk menetapkan kadar DMP, DOKS dan PSEU dalam sediaan tablet dan sirup dan memenuhi syarat validasi.