Sophi Damayanti
Institut Teknologi Bandung

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Analytical Method Development of Content and Dissolution Assay of Ursodeoxycholic Acid Capsule Wanti Megawati; Sophi Damayanti
Indonesian Journal of Pharmaceutical Science and Technology Vol 8, No 3 (2021)
Publisher : Indonesian Journal of Pharmaceutical Science and Technology

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24198/ijpst.v8i3.31420

Abstract

Ursodeoxycholic acid is an active compound to treat cholesterol gallstones which is included in Biopharmaceutical Classification System class II. Ursodeoxycholic acid capsule formulations have been developed by the pharmaceutical industries. Due to requirement, active ingredient testing and dissolution tests need to be routinely carried out to control quality of the drug. Therefore, aim of this study was to develop a simultaneously analytical method for assay and dissolution test. Optimum condition of analysis were using HPLC-RID, C18 column (5 µm; 3.9 x 300 mm), flow rate 1 mL/min, 50 µL volume injection, acetonitrile:buffer phosphate pH 3.0 (55:45 v/v) as mobile phase, column, detector, and sample temperature were 40 oC. This method provides good linearity in a range of 50-130 % concentration for assay and dissolution test with correlation coefficient values of 1 and 0.9995, respectively. LOD and LOQ for assay were in value of 4.892 µg/mL and 14.824 µg/mL whereas for dissolution tests in a value of 6,501 µg/mL and 19,701 µg/mL. The average percent recovery for assay and dissolution test were in a range of 100.018±0.888% and 98.936±2.124 %. Repeatability and intermediate precision of assay were obtained by determining RSD values of 0.466% and 0.279-0.483 %, while the dissolution test were 1.137% and 0.032-0.289 %. The validation show this method are linear, selective, accurate, and precise.Keywords: Assay, dissolution test, Ursodeoxycholic acid, validation
FORMULASI DAN UJI POTENSI ANTIOKSIDAN NANOSTRUCTURED LIPID CARRIER (NLC) RETINIL PALMITAT Framesti Frisma Sriarumtias; Sasanti Tarini Darijanto; Sophi Damayanti
Acta Pharmaceutica Indonesia Vol. 42 No. 1 (2017)
Publisher : School of Pharmacy Institut Teknologi Bandung

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Abstract

ABSTRAK Retinil palmitat (RP) merupakan golongan retinioid, yaitu ester vitamin A (Retinol) yang memiliki gugus palmitat pada ujung rantainya. Retinil palmitat banyak digunakan sebagai antioksidan dan anti kerut dalam industri kosmetika. Hal yang perlu diperhatikan dalam formulasi RP yaitu menjaga stabilitas dari panas, cahaya dan oksigen, sehingga perlu dicari sistem yang mampu melindungi RP dari degradasi. Salah satunya dibuat dalam sistem Nanostructured lipid carriers (NLC), sebagaimana diketahui bahwa NLC merupakan sistem penghantaran obat yang bisa meminimalisir degradasi. Tujuan penelitian ini adalah untuk mengembangkan sistem penghantaran NLC untuk meningkatkan stabilitas serta potensi antioksidan dan meningkatkan difusi RP melalui kulit. Bahan-bahan yang digunakan untuk pembuatan NLC dengan metode teknik mikroemulsi yaitu 4% PEG-8 beeswax dan 4% Isopropil miristat sebagai lipid padat dan lipid cair, 13% Polisorbat 80 sebagai surfaktan, dan 10% Sukrosa stearat sebagai kosurfaktan. Karakterisasi yang dilakukan yaitu pengukuran ukuran partikel dan polidisperistas indeks, efisiensi penjerapan, uji difusi dengan Franz diffusion cell, karakterisasi morfologi dengan Transmission electron microscopy (TEM) dan uji aktivitas antioksidan dengan DPPH. NLC-RP memiliki ukuran partikel 65,63±1,09 nm, indeks polidispersitas 0,32±0,07, efisiensi penjerapan 94,55±0,76%, hasil uji difusi tertinggi yaitu pada NLC-RP 52,58±4,37%, diikuti krim NLC-RP 36,36±1,46%, krim RP 18,70±2,13% dan emulsi RP 18,22±1,50%. Uji stabilitas fisika dan kimia NLC-RP disimpan selama 60 hari pada suhu 25°C RH 65% dan 40°C RH 75% menunjukan bahwa tidak ada perubahan pada kondisi tersebut. Dari penelitian ini didapat kesimpulan bahwa NLC-RP mampu menjaga stabilitas retinil palmitat. Sedangkan NLC-RP yang dimasukan kedalam krim mengalami penurunan kadar sebanyak 58,15% pada suhu ruang dan 70,05% pada suhu 40°C serta penurunan potensi antioksidan akibat keberadaan basis krim.Kata kunci: antioksidan, DPPH, nanostructured lipid carrier, retinil palmitatRETINYL PALMITATE NANOSTRUCTURED LIPID CARRIER (NLC) FORMULATION AND ANTIOXIDANT POTENTIAL TEST ABSTRACT Retinyl palmitate (RP), member of retinoid family is an ester of retinol with palmitate functional group at the end of the chain. RP is commonly used as antioxidants and anti-wrinkle component in cosmetic industry. RP instability requires a formulation system which makes it stable against heat, light and oxygen, such as Nanostructured Lipid Carriers (NLC). NLC is known as notable drug delivery system to minimize degradation. The aim of this research is to develop NLC delivery system to improve stability and antioxidant activity and increase RP diffusion through the skin. Materials used in NLC formulation were obtained using microemulsion technique are 4% PEG-8 beeswax and 4% isopropyl myristate as lipids in solid and liquid form, respectively; 13% polysorbate 80 as surfactant and 10% sucrose stearate as cosurfactant. Characterization NLC were evaluated using particle size measurement, polydispersity index, entrapment efficiency, in vitro diffusion testing using Franz diffusion cell, morphological characterization using Transmission Electron Microscopy (TEM) and antioxidant activity using DPPH. Particle size of NLC-RP was 65,63±1,09 nm, polydispersity index of 0,32±0,07, entrapment efficiency of 94,55±0,76%. Penetration result showed liquid NLC-RP difusion the highest 52,58±4,37%, followed by NLC-RP in cream 36,36±1,46%, RP in cream 18,70±2,13% and RP in emulsion 18,22±1,50%. Physical and chemical stability testing NLC-RP were stored for 60 days at 25°C RH 65% and 40°C RH 75%, the results shown there are no changed in these condition. Research results showed NLC-RP is able to maintain stability of RP, meanwhile NLC RP in cream formulation shows 58.15% amount decrease in room temperature and 70.05% amount decrease at 400C, and antioxidant activity decrease due to cream formulation.Keywords: antioxidant, DPPH, nanostructured lipid carrier, retinyl palmitate