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Penetapan Kadar Senyawa Obat Sulfadiazin Generik dan Paten dengan Metode Titrasi Bromometri Nilsya Zebua; Ristina Hasibuan; Syarifah Nadia; Khiru Nisa; Ibnu Abqori; Haya Meisha Nova; Habibatu Rohma; Fitri Khadrah Ardiany; Fina Cornelya Batubara; Ananda Wulan Sari Halwa
Journal of Educational Innovation and Public Health Vol. 4 No. 4 (2026): Oktober : Journal of Educational Innovation and Public Health
Publisher : Lembaga Pengembangan Kinerja Dosen

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.55606/innovation.v4i4.10371

Abstract

Background: Quantitative analysis of pharmaceutical preparations is essential to ensure active ingredient purity and content comply with quality standards. Sulfadiazine is a sulfonamide antibiotic whose content can be determined using bromometric redox titration. Objective: This study aimed to determine and compare the concentration of sulfadiazine in generic and patented dosage forms using the bromometric titration method. Methods: Assays were performed in triplicate (). Samples were dissolved in concentrated  and reacted with excess 0.1 N  and  to generate  gas in situ. The excess  was reacted with  and back-titrated using 0.1 N  with starch indicator until the blue color disappeared. Results: The mean concentration of generic sulfadiazine was  (, , and ), while the patented formulation was  (, , and ). Both preparations complied with the Indonesian Pharmacopoeia requirements (). Conclusion: There was no significant difference in active ingredient concentration between generic and patented preparations (0.36% difference), proving that generic sulfadiazine has equivalent quality and chemical efficacy to its patented counterpart.
Penetapan Kadar Senyawa Obat Sulfametaksazol Generik dan Paten Dengan Metode Titrasi Nitrimetri Nilsya Zebua; Ristina Hasibuan; Syarifah Nadia; Mutia Syadilla; Nazwa Zahra; Aliya Nabila Mulki; Nabila Zuhdi; Nurul Athifah Trisma Tanjung; Nabila Dwi Audiva; Naura Syakilah; Dea Ramadhani
RIGGS: Journal of Artificial Intelligence and Digital Business Vol. 5 No. 2 (2026): Mei-Juli
Publisher : Prodi Bisnis Digital Universitas Pahlawan Tuanku Tambusai

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.31004/riggs.v5i2.13842

Abstract

Kualitas dan kadar zat aktif obat merupakan parameter penting dalam menjamin mutu, keamanan, dan efektivitas sediaan farmasi, baik pada obat generik maupun obat paten. Sulfametoksazol merupakan antibiotik golongan sulfonamida yang memiliki gugus amina aromatis primer sehingga dapat ditetapkan kadarnya melalui reaksi diazotasi dengan metode titrasi nitrimetri.Penelitian ini bertujuan menetapkan serta membandingkan kadar zat aktif sulfametoksazol pada sediaan generik dan paten menggunakan metode titrasi nitrimetri. Penelitian dilakukan secara eksperimental laboratorium dengan pengujian triplo. Sampel dilarutkan dalam HCl 25%, ditambahkan KBr sebagai katalis, kemudian dititrasi menggunakan larutan NaNO2. Penentuan titik akhir dilakukan melalui indikator dalam, yaitu campuran Tropeolin OO dan Biru Metilen, serta indikator luar berupa pasta kanji-iodida. Pengujian menunjukkan kadar sulfametoksazol generik sebesar 99,5%, 97,0%, dan 94,7% dengan rata-rata 97,07%, sedangkan sediaan paten memperoleh kadar 95,5%, 97,4%, dan 98,0% dengan rata-rata 96,97%. Kedua sediaan berada pada rentang persyaratan kadar Farmakope Indonesia, yaitu 90,0%-110,0% dari jumlah yang tertera pada etiket. Selisih rata-rata kadar kedua sediaan hanya 0,10 poin persentase, sehingga secara deskriptif menunjukkan kandungan zat aktif yang relatif setara. Metode nitrimetri dapat digunakan untuk penetapan kadar sulfametoksazol yang memiliki gugus amina aromatis primer. Hasil penelitian menunjukkan bahwa sediaan generik dan paten sama-sama memenuhi persyaratan kadar, sehingga temuan ini mendukung bahwa obat generik dapat memenuhi standar mutu kimia pada parameter kadar zat aktif.
Determination Of The Level Of Medium Acid Drug Compounds By Semi-Water-Free Titration Nilsya Febrika Zebua; Ristina Hasibuan; Nerdy Nerdy; Habiba Siti Ardhila; Pingkan Pingkan; Siti Nur Azizah; Muhammad Aidil; Revalia Putri Nirwana; Jessica Rany; Hafifah Izmanaini Nasution
International Journal of Health Engineering and Technology Vol. 5 No. 3 (2026): SEPTEMBER 2026
Publisher : CV. AFDIFAL MAJU BERKAH

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.55227/ijhet.v5i3.1182

Abstract

Salicylic acid is a compound widely used in topical preparations, so determining its levels is necessary to ensure product quality and safety. This study aims to determine the levels of salicylic acid in salicylic acid and salicyl powder samples using the semi-aqueous titration (TSBA) method. The study was conducted experimentally in a laboratory using 0.1 N NaOH as a titrant and phenolphthalein as an indicator. Each sample was analyzed three times. The results showed that the salicylic acid levels were 27.63%, 42.78%, and 24.79%, respectively, while the levels in the salicyl powder sample were 80.01%, 87.10%, and 88.12%. Variations in levels between repetitions can be influenced by weighing accuracy, sample homogeneity, dissolution process, burette reading, and titration endpoint determination. The TSBA method can be used as a simple method for quantitative determination of salicylic acid compounds.