UJI PRESISI DAN PROFIL DISOLUSI TABLET LOSARTAN INOVATOR DAN COPY PRODUCT DENGAN METODE SPEKTROFOTOMETRI ULTRAVIOLET-VISIBLE

Authors

  • Wahyunita Yulia Sari
  • Ika Yuni Astuti
  • Didik Setiawan

DOI:

https://doi.org/10.30595/pji.v7i1.548

Abstract

ABSTRAK Uji disolusi in-vitro digunakan untuk meneliti pelepasan obat dan sebagai dasar memperkirakan bioavaibilitas. Penelitian ini bertujuan untuk mengetahui presisidari metode yang digunakan dan mengetahui profil disolusi dari sediaan tablet yang mengandung losartan baik yang inovator maupun copy product (A, B, C, dan D). Metode untuk presisi dari metode disolusi dan profil disolusi tablet losartan, dilakukan dengan metode spektrofotometeri ultraviolet-visible. Presisi merupakan salah satu parameter dalam validasi metode disolusi. Uji disolusi tablet losartan inovator dan copy product (A, B, C, dan D) dilakukan pada medium aquabidestilata dengan kecepatan putaran dayung 50 rpm. Waktu pengambilan sampel dilakukan pada menit ke-0; 5; 10; 15; 20; 25; 30; 35; 40; 45. Hasil uji diperoleh keseksamaan (nilai KV = 2,0128 %), sedangkan profil disolusi jika dilihat dari nilai f2, menunjukan bahwa tablet losartan copy product B dan D memiliki kesamaan dengan tablet losartan inovator. Namun hasil ini memiliki perbedaan dengan hasil analisis anova, yang memperlihatkan bahwa tablet losartan copy product D memiliki perbedaan dengan tablet losartan inovator. Perbedaan ini dapat dilihat dari hasil analisis menggunakan anova yang dilanjutkan dengan LSD. Kata kunci: losartan; validasi metode; disolusi; inovator; copy product ABSTRACT The examine of dissolution in-vitro is used to research drug releated and for basis of bioavaibility prediction. This research aimed to search for precision from the methode is used and to search for profile of dissolution from losartan tablet of inovator although copy product (A, B, C, and D). A method for precision by dissolution method and profile of dissolution losartan tablet, had been developed using spektrofotometri ultraviolet-visible method. Presicion is one of parameters in validation dissolution method. Test of dissolution inovator and copy product (A, B, C, and D) losartan tablet had been developed using aquabidestilata medium with rapid of paddle rotate is 50 rpm. The time of sample withdrawal had been developed at 0; 5; 10; 15; 20; 25; 30; 35; 40; 45 minutes. The result shown the precision (CV value to 2,0128%), but profile of dissolution mention that copy product B and D losartan tablet have indentically with inovator losartan tablet from the value of f2. But it is difference with result of anova analysis, the mention that copy product D losartan tablet have difference with inovator losartan tablet. This difference can be seen from result of analysis by anova and then with LSD. Key words : losartan; validation of method; dissolutioni; inovator; copy product.

References

Abdou, H. M. 1989. Dissolution, Bioavaibilitas dan Bioekivalen. Mack publishing compeny. Easton. Tensy Vania.

Anonim. 1979. Farmakope Indonesia Ed. III. Jakarta : Departemen Kesehatan Republik Indonesia. Hlm 7.

Anonim. 1995. Farmakope Indonesia Ed. IV. Jakarta : Departemen Kesehatan Republik Indonesia. Hlm 1083-1085.

Anonim. 2000. Sukses A-II-RA sebagai Antihipertensi. Volume 1, Nomor 1.

Anonim. 2007. Cozaar Drug Description. http://www.rxlist.com/cozaar-drug.htm. (1 Desember 2008)

Anonim. 2008. ISO Indonesia. Volume 43. Jakarta : ISFI.

Harmita. 2004. Petunjuk Pelaksanaan Validasi Metode Dan Cara Perhitungannya. Majalah Ilmu Kefarmasian, Vol. 1, No. 3 : 117135.

Nurhayati, S. 2005. Penetapan Kadar dan Uji Disolusi Parasetamol dalam Paracetamol 500 mg Tablet Secara Spektrofotometri UV [Tugas Akhir]. Bogor : Akademi Kimia Analisis.

Shargel, L., dan Yu, A. B. C. 2005. Biofarmasetika dan Farmakokinetika Terapan (Terjemahan) Fasichs. S Ed. 2. Surabaya: Airlangga University Press. Hal. 34-110.

Silverstein, Bassler, Morill. 1991. Spectrometric Identification of Organic Compounds. Fifth Edition. Singapore : John Wiley & Sons.

Siregar C, Agoes G, Logawa B. 1992. Validasi Di Industri Farmasi. Sukmadjaja A; Mar’u UU; Badruzzaman S; editor; ITB, 1 Mei 1992. Bandung : Institut Teknologi Bandung. Hlm.55-58.

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Published

2010-04-01

How to Cite

Sari, W. Y., Astuti, I. Y., & Setiawan, D. (2010). UJI PRESISI DAN PROFIL DISOLUSI TABLET LOSARTAN INOVATOR DAN COPY PRODUCT DENGAN METODE SPEKTROFOTOMETRI ULTRAVIOLET-VISIBLE. PHARMACY: Jurnal Farmasi Indonesia (Pharmaceutical Journal of Indonesia), 7(01). https://doi.org/10.30595/pji.v7i1.548

Issue

Jurnal Pharmacy, Vol. 07 No. 01 April 2010

Section

PHARMACY

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