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Abstrak :
ABSTRAK
Esomeprazol ESO merupakan salah satu obat golongan Proton Pump Inhibitor PPI berbentuk tablet salut selaput yang merupakan sediaan lepas termodifikasi sehingga wajib diuji bioekivalensi dengan metode bioanalisis yang selektif, sensitif, dan valid. Teknik biosamplingdried blood spot DBS sedang dikembangkan karena beberapa kelebihan dari teknik ini terkait kestabilan analit, keamanan, kenyamanan subjek, kemudahan penanganan, dan ekonomis. Penelitian ini bertujuan untuk mengembangkan metode analisis ESO dalam sampel DBS menggunakan Kromatografi Cair Kinerja Tinggi KCKT dengan detektor Photodiode Array PDA. Sampel darah ditotolkansebanyak 30mL, dikeringkan selama 2,5 jam, diekstraksi menggunakan metanol sebanyak 500L, dikocok menggunakan vortex selama 3 menit, dan disonikasi selama 15 menit. Hasil ekstraksi disentrifugasi selama 1 menit dan supernatan diuapkan di bawah aliran gas nitrogen pada suhu 40 C. Residu direkonstitusi menggunakan fase gerak kemudian dianalisis menggunakan KCKT fase terbalik dengan kolom Waters, SunfireTM5; 250 x 4,6mm ; fase gerak asetonitril dapar fosfat pH7,6 40:60 ; laju alir 1,0mL/menit; suhu kolom 40 C; deteksi pada panjang gelombang 300 nm; waktu analisis selama 10 menit; menggunakan lansoprazol sebagai baku dalam. Hasil validasi terhadap metode analisis ESO yang dilakukan memenuhi persyaratan validasi berdasarkan EMEA pada tahun 2011. Metode analisis linear pada rentang konsentrasi 70,0-1400,0ng/mL dengan nilai r>0,98.

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ABSTRACT
Esomeprazole ESO is a Proton Pump Inhibitor which is classified to modified release dosage form, so that must be tested for bioequivalence with a selective, sensitive, and valid bioanalysis method. Dried blood spot DBS technique is being developed for its advantages related to analyte stability, safety, practicality, less invasive, and cheaper. This study aims to develop the method of ESO analysis in a DBS sample using High Performance Liquid Chromatography HPLC with Photodiode Array detector. 30mLwhole blood sample was spotted and dried for 2,5 hours, extracted with 500L methanol, vortex mixed for 3 minutes, and sonicated for 15 minutes. The extract then was sentrifuged for 1 minutes and the supernatant was evaporated under nitrogen flow at 40 C. Residue was reconstituted with mobile phase then analysed with reversed phase HPLC with column Waters, SunfireTM 5 m 250 x 4.6mm acetonitrile phosphate buffer pH7.6 40 60 as the mobile phase flow rate was 1.0mL min column temperature was 40 C detection wavelength was 300 nm analysis time was 10 minutes using lansoprazole as the internal standard. The results of bioanalysis method validation performed met the validation criteria based on EMEA in 2011. The method was linear at concentration range of 70.0 1400.0ng mL with r 0.98.

Abstrak :
Praktik kerja profesi apoteker Universitas Indonesia dilaksanakan di salah satu industri farmasi yaitu PT Mahakam Beta Farma dengan alamat Jalan Pulokambing Raya Nomor 20, Kawasan Industri Pulogadung, Jakarta Timur. Beberapa tujuannya adalah membantu mahasiswa calon apoteker untuk memahami peranan, tugas dan tanggung jawab apoteker di Industri farmasi, memiliki wawasan, pengetahuan, keterampilan dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi, memahami penerapan CPOB di industri farmasi dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Praktik kerja profesi dilaksanakan selama delapan minggu dengan tugas khusus ldquo;Validasi Metode Disolusi Zat Aktif A dan Zat Aktif B dalam Kaplet Salut Selaput rdquo;. Tujuan dari tugas khusus ini adalah memahami validasi metode disolusi pada PT Mahakam Beta Farma, memperbaharui validasi metode disolusi sesuai dengan USP 40, menjamin metode disolusi yang digunakan akan memberikan hasil yang terpercaya. ...... Apothecary Internship in the pharmaceutical industry, one of which was PT Mahakam Beta Farma and located in Pulokambing Raya Road number 20, Kawasan Industri Pulogadung, East Jakarta. The purpose was to assist students as a future pharmacist to understand roles, duties and responsibilities, to gain insight, knowledge, skill and experience to perform pharmaceutical duties, to understand Good Manufacturing Process GMP and to apprehend real pharmaceutical related problems especially as a pharmacist in the pharmaceutical industry. The internship was conducted for eight weeks with special assignment titled ldquo;Dissolution Method Validation of Active Pharmaceutical Ingredients A and Active Pharmaceutical Ingredients B in Coated Caplet rdquo;. The purpose of this special assignment was to understand validation method dissolution at PT Mahakam Beta Farma, to update validation method dissolution using USP 40 and to assure validation method dissolution will provide credible result.

Abstrak :
ABSTRACT
Optimization and method validation of HPLC with fluorescence detector for the determination of benzo[c]fluorene were studied. The results showed that benzo[c]fluorene had a maximum excitation wavelength at 309 nm and a maximum emission wavelength at 354 nm. The mixture of acetonitrile-water was used as a mobile phase at a ratio of 85:15. The standard curve was linear over the concentration range of 0.5-50 ng/ml. The limit of detection and the limit of quantification were 0.27 ng/ml and 0.90 ng/ml, respectively. The relative standard deviation of precision for intra-day and inter- days were less than 5% for both low (5 ng/ml) and high (50 ng/ml) concentration of benzo[c]fluorene. The method was validated and showed satisfactory results of linearity, precision, limit of detection, and limit of quantification. Accuracy in terms of percent recovery strongly depends on sample matrix. Therefore, further studies are needed to investigate the accuracy when the method is applied in the real sample such as environmental and food samples.

Abstrak :
Industri farmasi merupakan industri yang memproduksi suatu obat. Setiap industri farmasi harus mampu memenuhi kriteria Cara Pembuatan Obat yang Baik (CPOB) agar dapat menjamin dan menghasilkan produk yang bermutu. Industri farmasi yang memproduksi produk sediaan steril harus memenuhi persyaratan fisika, kimia dan bebas dari mikroorganisme baik bakteri maupun jamur, maka dari itu harus dilakukan validasi untuk memberikan jaminan telah efektifnya proses sterilisasi pada sediaan steril yang telah diproduksi. Tujuan penelitian ini yaitu untuk melakukan validasi metode analisa stasis test pada uji sterilitas produk sediaan steril di PT. Mahakam Beta Farma. Penelitian dilakukan pada tanggal 03 Juli - 31 Agustus 2023 di Departemen Quality Control (QC) PT. Mahakam Beta Farma. Hasil dari validasi metode analisa stasis test yang telah dilakukan bahwa hasil dari validasi sudah valid karena hasil pengujian sudah sesuai dengan kriteria keberterimaan yang sudah ditetapkan pada protokol validasi uji sterilitas produk sediaan steril di PT. Mahakam Beta Farma. ...... The pharmaceutical industry is an industry that produces drugs. Every pharmaceutical industry must be able to meet the criteria for Good Medicine Manufacturing Practices (CPOB) in order to guarantee and produce quality products. The pharmaceutical industry that produces sterile preparation products must meet physical, chemical requirements and be free from microorganisms, both bacteria and fungi, therefore validation must be carried out to provide assurance that the sterilization process has been effective for the sterile preparations that have been produced. The aim of this research is to validate the stasis test analysis method for sterility testing of sterile preparation products at PT. Mahakam Beta Farma. The research was conducted on 03 July - 31 August 2023 at the Quality Control (QC) Department of PT. Mahakam Beta Farma. The results of the validation of the stasis test analysis method that have been carried out show that the results of the validation are valid because the test results are in accordance with the acceptance criteria that have been determined in the sterility test validation protocol for sterile preparation products at PT. Mahakam Beta Farma.

Abstrak :

Sediaan krim hidrokinon (HIK), deksametason (DEK), triamsinolon asetonid (TSA), hidrokortison asetat (HIA), betametason valerat (BEV) dan asam retinoat (ARE) banyak digunakan pada kulit wajah agar terlihat halus dan cerah. Penelitian ini bertujuan menganalisis ke enam zat tersebut secara simultan dalam sediaan krim menggunakan kromatografi cair kinerja tinggi sistem gradien dengan detektor PDA. Sistem kromatografi yang digunakan terdiri dari kolom Waters X-Bridge C18, 5 µm (4,6x250) mm, fase gerak sistem gradien asam formiat 0,1 % (A) -asetonitril (B), laju alir terpilih 1,2 ml/menit dan suhu 40 ⁰C. Sampel dideteksi menggunakan detektor PDA Waters 2998 pada 210-400 nm, dengan teknik time wavelength. Metode ini divalidasi pada rentang 25 – 150 µg/mL untuk ke enam zat aktif,  dengan nilai Horrat untuk Presisi didapat nilai kecil dari 2, serta nilai perolehan kembali untuk 3 konsentrasi antara 99,05% - 100,96%. Nilai LOD dan LOQ dari perhitungan antara 1,19 μg/mL - 7,14 μg/mL untuk masing-masing zat aktif. Penggunaan metoda simultan ini pada analisis sampel krim yang beredar di pasaran, dari lima sampel tunggal yang diuji didapatkan hasil penetapan kadar yang memenuhi syarat pada rentang 90 – 110 % dari kadar yang tertera pada label.            

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Cream dosage form contain hydroquinone (HIQ), dexamethasone (DEX), triamsinolone acetonid (TSA), hydrocortisone acetate (HYA), betamethasone valerate (BEV) and retinoic acid (REA) was used for face skin, purpose smooth and bright result. The aim of this research is to analize this six components in cream using High Performance liquid Chromatography with gradient technique and Photo Diode Array (PDA) detector. The chromatography system consist of Waters X Bridge C18 5 μm column (4.6 mm × 250 mm) with gradien system mobile phase contain formic acid 0.1 % (A) - acetonitrile (B), flow rate was 1.2 ml/min and 400C column temperature. All separations were performed with a 2998 PDA detector on 210-400 nm wavelength, using time wavelength program.  This method was validated over the range 0f 25-150 µg/ml for the six components, the horrat value was under 2 for precision parameter and the mean recoveries in the range of 99.05 – 100.96%. The LOD and LOQ were found in the range 1,19 μg/mL - 7,14 μg/mL. The use of this method in quantitative analysis of single sample cream substances on the market, from five samples tested has eligible grade determination results in the range 90 - 110% of the levels indicated on the label.

 

Abstrak :
ABSTRAK
6-Merkaptopurin merupakan agen kemoterapi yang termasuk golongan antimetabolit analog purin. Penelitian ini bertujuan untuk menganalisis secara simultan 6-merkaptopurin 6-MP ,6-metilmerkaptopurin 6-MMP , dan 6-tioguanosin-5 39;-monofosfat 6-TGMP pada sampel darah kering dengan menggunakan kromatografi cair kinerja ultra tinggi-tandem spektrometri massa KCKUT-SM/SM . Sebanyak 60 ? ? L darah utuh ditotolkan pada kertas DBS-CAMAG, ditambahkan baku dalam 5-fluorourasil 5-FU kemudian diekstraksi menggunakan metanol 90 v/v . Analisis dilakukan dengan kolom Waters Acquity UPLC BEH AMIDA 1,7 ? ? m 2,1 x 100 mm dengan fase gerak campuran 0,2 v/v asam format dalam air minus;0,1 v/v asam format dalam asetonitril-metanol, elusi secara gradien dan laju alir 0,2 mL/menit. Deteksi massa dilakukan menggunakan Waters Xevo TQD dengan ionisasi electrospray ESI positif untuk 6-MP, 6-MMP, 6-TGMP dan ESI negatif untuk 5-FU dengan mode multiple reaction monitoring. Deteksi 6-MP, 6-MMP, 6-TGMP, 5-FU masing-masing adalah m/z 153,09 > 119,09; 167,17 > 126,03; 380,16 > 168,00 ; 129,09 > 42,05. Metode ini linier dengan kisaran 25,5 ndash;1020 ng/mL untuk 6 MP, 6-MMP, dan 6-TGMP. Metode ini valid untuk analisis 6-MP, 6-MMP, dan 6-TGMP pada sampel darah kering secara simultan secara in vitro sesuai dengan pedoman European Medicines Agency

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ABSTRACT
6-Mercaptopurine is a chemotherapeutic agent of the antimetabolite class. This study aims to analyze simultaneous validation of 6-mercaptopurine 6-MP , 6-methylmercaptopurine 6-MMP , and 6-thioguanosine-5 rsquo;-monophosphate 6-TGMP in dried blood spot DBS using ultra performance liquid chromatography-tandem mass spectrometry UPLC-MS/MS . An accurate volume of 60 ? ? ? ? ? ? ? ? L blood was spotted onto DBS-CAMAG paper and then extracted using methanol 90 v/v containing an internal standard of 5-fluorouracil 5-FU . Separation was performed using a Waters Acquity UPLC BEH AMIDA column 1.7 ? ? ? ? ? ? ? ? m 2.1 x 100 mm with a mobile phase mixture of 0.2 v/v formic acid in water minus;0.1 v/v formic acid in acetonitrile-methanol with gradient elution and flow rate of 0.2 mL/min. Mass detection was done using Waters Xevo TQD with positive electrospray ionization ESI for 6-MP, 6-MMP, 6-TGMP and negative ESI for 5-FU, in multiple reaction monitoring mode. Detection rates of 6-MP, 6-MMP, 6-TGMP and 5-FU were m/z 153.09 > 119.09; 167.17 > 126.03; 380.16 > 168.00 ; 129.09 > 42.05, respectively. This method is linear across the range 25.5 ndash;1020 ng/mL for 6-MP, 6-MMP and 6-TGMP. This method is valid for the in vitro simultaneous analysis of 6-MP, 6-MMP and 6-TGMP in DBS, based on European Medicine Agency guidelines.

Abstrak :
Jamu merupakan obat tradisional Indonesia yang telah dimanfaatkan masyarakat sejak dahulu. Beberapa orang menyalahgunakan jamu dengan cara menambahkan bahan kimia obat untuk meningkatkan efek terapi. Penggunaan bahan kimia obat pada jamu melanggar hukum yang ada serta berbahaya bagi masyarakat. Salah satu jamu yang sering ditambahkan bahan kimia obat adalah jamu rematik, dengan penambahan obat golongan anti inflamasi. Pada penelitian ini dilakukan validasi metode analisis dari Metampiron, Asam Mefenamat, dan Parasetamol di dalam jamu rematik menggunakan KLT Densitometri. Jamu yang telah diekstraksi dengan etanol dianalisis menggunakan KLT Densitometri dengan fase gerak toluen-etanol 6:4 . Batas deteksi dan kuantitasi metampiron, asam mefenamat, dan parasetamol berturut-turut 46,39 g/mL, 154,66 g/mL; 43,29 g/mL, 144,29 g/mL; dan 30,92 g/mL, 103,08 g/mL. Dari sepuluh sampel yang diperiksa, lima diantaranya positif mengandung parasetamol dengan kadar sampel WT 4,96 ,GS 3,98 , AK 5,95 , KJ 4,62 , dan MN 27,91. ......Jamu is a traditional medicine in Indonesia that has been used for centuries to maintain a good health. Some people add chemical drug into jamu to improve the therapeutic effect. This is a violation of the law and maybe harmful to health. Jamu for rheumatoid arthritis are often found contain added anti inflamatory drug. This study aims to validate analytical method of Methampyrone, Mefenamic Acid, and Paracetamol in jamu for rheumatoid arthritis by TLC Densitometry. The sample jamu was extracted ethanol is analyzed with TLC densitometry using toluene ethanol 6 4 as the mobile phase. This method was fulfilled the validation with limit of detection and limit of quantitation respectively for methampyrone, mefenamic acid, and paracetamol are 46.39 g mL, 154.66 g mL 43.29 g mL, 144.29 g mL and 30.92 g mL 103.08 g mL. Out of ten samples analyzed, five of them contained paracetamol at a concentration of WT 4.96 ,GS 3.98 , AK 5.95 , KJ 4.62 , and MN 27.91.

Abstrak :
Pekerjaan kefarmasian yang dilakukan di industri farmasi antara lain pengendalian mutu sediaan farmasi, pengadaan, pengamanan, penyimpanan, serta pengembangan obat, bahan obat, dan obat tradisional. Industri farmasi diwajibkan untuk memenuhi persyaratan Cara Pembuatan Obat yang Baik (CPOB). Apabila suatu industri farmasi tidak menerapkan CPOB, maka akan berdampak terhadap keselamatan pasien. Praktik kerja profesi apoteker di PT Merck Tbk bertujuan untuk memahami peranan, tugas, dan tanggung jawab apoteker di industri farmasi; memiliki wawasan, pengetahuan, ketrampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi; memahami penerapan CPOB di industri farmasi, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang dikerjaan mengenai Validasi Metode Analisis Nikotinamida (Vitamin B3) Menggunakan KCKT pada Sirup Multivitamin. ...... Pharmaceutical works practiced in pharmacy industry are pharmaceutical preparation quality control, safekeeping, and the development of drugs, drug raw materials, and traditional medicines. Pharmacy industry is obligated to fulfill the requirements of Good Manufacturing Practice (GMP) of drugs. If a pharmacy industry doesnt apply the GMP, it will impact the patient safety. The objective of apothecary profession internship practice at PT Merck Tbk were comprehending the role, duty, and responsibility of apothecary in pharmacy industry; having knowledges, skills, and practical experience in executing pharmaceutical work in pharmacy industry; comprehending the application of GMP for drugs in pharmacy industry; and having real description of pharmaceutical work issue in pharmacy industry. The special assigment created was about Analytical Method Validation of Nicotinamide (Vitamin B3) Using HPLC in Multivitamin Syrup.

Abstrak :
Praktik kerja profesi di PT. Ethica Industi Farmasi joint venture with Fresenius Kabi Cikarang Periode Bulan Juli ndash; Agustus 2017 bertujuan untuk mengerti peranan, tugas, dan tanggung jawab apoteker di Industri Farmasi dan memahami penerapan Cara Pembuatan Obat yang Baik CPOB di Industi Farmasi. Selain itu calon apoteker juga dapat memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan yaitu berjudul ldquo;Penentuan Metode Analisis Penetapan Residu Senyawa Marker Validasi Pembersihan rdquo;. Tujuan dari tugas khusus ini adalah membuat dan mengkaji protokol metode analisis penetapan residu senyawa marker untuk validasi pembersihan. Secara umum, PT. Ethica Industi Farmasi joint venture with Fresenius Kabi telah menerapkan 12 aspek CPOB dengan baik dan benar, penulis juga telah mendapatkan kemampuan untuk memahami peran, tugas, wawasan dan tanggung jawab apoteker dan memberikan solusi pada permasalahan di industri farmasi.

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Internship at at PT. Abbott Indonesia Period July - August 2017 aims to understand the roles, duties and responsibilities of pharmacists in the pharmaceutical industry and the understanding of the application of good manufacturing practice GMP in the pharmaceutical industry. In addition, the pharmacist candidate can also have the insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry. The special assignment given is ldquo;Analysis Method Determination of Marker Residue Compound for Cleansing Validation rdquo;. The purpose of this special assignment is study the protocol of residue analysis of marker residue compound for cleaning validation. In general, PT. PT. Ethica Industi Farmasi joint venture with Fresenius Kabi has applied 12 aspects of GMP well and correctly, the authors also have the ability to understand the roles, duties, insights and responsibilities of pharmacists and provide solutions on products in the industry pharmacy.

Abstrak :
ABSTRAK
Praktek Kerja Profesi di PT Merck Tbk dilaksanakan selama 2 bulan yaitu pada tanggal 1 Agustus 2016 hingga tanggal 30 September 2016 di Departemen Pengawasan Mutu. Tujuan dari praktek kerja yang dilakukan adalah untuk memberikan gambaran, pengetahuan, dan pengalaman praktis kepada calon apoteker terutama mengenai kegiatan di Industri Farmasi. Kegiatan praktek kerja hampir semuanya dilaksanakan di Departemen Pengawasan Mutu. Namun, kunjungan ke departemen lain juga dilakukan seperti kunjungan ke departemen Pemastian Mutu, Produksi, Pengemasan, Supply Chain Management, Product Process Innovation, Environment Quality, dan Engineering. Pelaksanaan pembuatan obat yang dilakukan di PT Merck Tbk telah menerapkan prinsip Cara Pembuatan Obat yang Baik. Selain mempelajari tugas dari masing-masing departemen, penulis memiliki Tugas Khusus yaitu melakukan Validasi Metode Analisis untuk Sediaan Tablet Mulvitamin dan Mineral dengan menggunakan Spektrofotometri Serapan Atom. Tujuan dari tugas khusus ini adalah untuk memperoleh metode yang valid dalam analisis mineral menggunakan Spektrofotometri Serapan Atom.

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ABSTRACT
Internship at PT Merck Tbk was held for two months started from August 1st, 2016 until September 30th, 2016 in Quality Control Department. The aim of internship are to give a description, knowledge, and practice experience for apothecary student especially in Pharmaceutical Industry activites. Internship program mostly was held in Quality Control Department. However, during internship, we visited another department too like Quality Assurance Department, Production Department, Packing Department, Supply Chain Management Department, Product Process Innovation Department, Environment Quality Department, and Engineering Department. Manufacturing Product which held by PT Merck Tbk has implemented Good Manufacturing Product Principle. In addition to studying about role which each other department, a writer had special assigment. The special assignment was Analytical Method Validation for Multivitamins and Minerals Tablets with using Atomic Absorption Spectrophotometry. This special assigment aims to obtain a valid method in analysing of mineral with using Atomic Absorption Spectrophotometry.