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Validasi Metode Analisis Rebamipid Dalam Plasma In Vitro Secara Kromatografi Cair Kinerja Tinggi-Ultraviolet Harahap, Yahdiana; Alia, Nu
Majalah Ilmu Kefarmasian Vol. 6, No. 3
Publisher : UI Scholars Hub

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Rebamipide is antiulcer agent and it is one of the drug that have to be evaluated with bioequivalency test according to Food and Drug Administration (FDA). The objec-tive of this research is to find out the optimum condition of rebamipide in human plasma in vitro analysis by High Performance Liquid Chromatography (HPLC) with ultraviolet detector, and then the method was validated. The chromatography was carried out by isocratic technique on a reversed-phase Kromasil® C18 (5 µm, Akzo Nobel), column length was 250 x 4.6 mm, with mobile phase consisted of acetonitrile - phosphate buffer pH 3.0 (40:60) at flow rate of 1.0 ml/min, and detection was performed at wavelength of 230 nm. The sample preparation technique was liquid-liquid extraction by phosphoric acid and ethyl acetate. Carbamazepine was used as the internal standard. The method was valid according to FDA in Bioanalitycal Method Validation, with coefficient correlation of 0.9993 and linear in the range concentra-tion of 0.04 – 1.2 µg/ml, the lower limit of quantitation was 42.0 ng/ml, precision less than 6% and recovery percentage was 90.32 to 113.45%. Rebamipide in plasma was stable for 14 days storage in -200C.
Analisis Asam Valproat dalam Plasma Secara Kromatografi Gas Susanti, Ani; Harahap, Yahdiana; Harmita, Harmita
Majalah Ilmu Kefarmasian Vol. 7, No. 3
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Valproic acid is an anticonvulsant drug that works by increasing the levels of γ-aminobutyric acid (GABA). Determination of valproic acid is quite difficult because it has no chromophore groups in its structure. Aa analytical method using gas chromatography (GC) with flame ionization detector for the determination of valproic acid in human plasma has been developed and optimized. Valproic acid was extracted from plasma by liquid-liquid extraction method using diethyl ether. The optimum analysis conditions for valproic acid in plasma were achieved by regulated gas chromatography injector and detector at a temperature of 250oC and temperature programming with an initial temperature of 70oC and 5oC temperature increasing per minute until a temperature of 100oC, then held for 1 minute. Then the temperature was increased by 2°C per minute until the column temperature to 150oC. The optimum conditions of analysis took 32 minutes. In the concentration range from 40.0 to 100.0 µg/mL yielded a linear calibration curve with correlation coefficient (r) of 0.9894. Accuracy (% diff) of this method was -13.67% to 12.33% with precision (CV) between 9.33% to 14.92%, and relative recovery test was 86.33% to 112.33%.
Penetapan Kadar Sakarin, Asam Benzoat, Asam Sorbat, Kofeina, Dan Aspartam Di Dalam Beberapa Minuman Ringan Bersoda Secara Kromatografi Cair Kinerja Tinggi Hayun, Hayun; Harahap, Yahdiana; Azizah, Citra Nur
Majalah Ilmu Kefarmasian Vol. 1, No. 3
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As the food and beverages industry grows in Indonesia, there also has been an increase in the soft-drinks production in the society. There are elements often added into the drinks; such as caffeine, artifical sweetener and preservatives,which the content should be monitored. Because, if they are over-used, they will be hazardous to health. The purpose of this research is to obtain the optimum analysis condition for determining the content of saccharin, aspartame, benzoic acid, sorbic acid and caffeine, which are in the soft-drinks, using the reversed phase High-Performance- Liquid-Chromatography (HPLC). In this study, the condition used are Latek 18 column (15 cm x 4.0 mm), mobile phase as a mixture of acetonitrile and acetat buffer pH 5(5:95), flow rate 1,0 ml/minutes and detected by a 254 nm length-wave. The detection limit discovered by this method are for saccharin, benzoic acid, sorbic acid, caffeine and aspartame, respectively, are 0,2 ppm; 0,2 ppm; 0,007 ppm; 0,142 ppm; and 6,5 ppm. Whereas, the quantitative limit for saccharin, benzoic acid, sor- bic acid, caffeine and aspartame, respectively, are 0,689 ppm; 0,852 ppm; 0,027 ppm; 0,452 ppm; 25,2 ppm. The calibration curve ranged between 1-60 ppm for saccharin and benzoid acid, 1-40 ppm for caffeine, 0.05-2 ppm for sorbic acid, and 30-100 ppm for aspartame. The investigation has been done for five (5) brands od soft-drinks. The analysis results are sample A contains caffeine 96,66 ppm, sample B contains saccharin 112,13 ppm, benzoic acid 206,81 ppm, and caffeine 130,63 ppm. Sample C contains benzoic acid 10,83 ppm and caffeine 97,66 ppm. Sample D con- tains benzoic acid 163,78 ppm, caffeine 101,52 ppm, and aspartame 231,20 ppm. The amounts of saccharin, benzoic acid, caffeine, and aspartame which has been found in the sample, do not exceed the tolerance limit of usage, whereas the amount of benzoic acid which has been found in sample B exceed the tolerance limit of usage.
Analisis Adduct DNA Setelah Pemberian Natrium Nitrit dan Dimetilamin Secara Berulang Pada Tikus Meilianti, Sherly; Harahap, Yahdiana; Hayun, Hayun
Majalah Ilmu Kefarmasian Vol. 8, No. 1
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Nitrosodimethylamine is a carcinogenic compound which can be formed from the reaction of nitrite and dimethylamine that is found in food. Nitrosodimethylamineis activated in liver and alkylates the DNA base and producing a DNA adductssuch as O6-methylguanine and N7-methylguanine that have a role incarcinogenesis. In this research, DNA was isolated from rat’s blood which waspreviously given nitrosodimethylamine’s precursor, sodium nitrite anddimethylamine. DNA adducts can be obtained from hydrolysis in hydrochloricacid 0.1 N for 30 minutes at 7000C. Then the adducts were analyzed using High Performance Liquid Chromatography (HPLC), with a strong cation exchangecolumn (Supelcosil LC-SCX, 5 μm, 250 x 4.6 mm), mobile phase consisting ofammonium phosphate with a final concentration of 40 mM, pH 3.00, flow rate 1.5mL/minute, column temperature 30oC and detected at exitation wavelength 286 nm and emission wavelength 366 nm. This method gave an acceptable validation result according to accuracy and precicion test results that fulfill the requirementand linear calibration curve with a quantitation limit of 22,5403 ng/mL. Rats were divided into six groups that two groups were given nitrosodimethylamine aspositive control, three groups were given prekursor, and the other was normalcontrol. Blood samples were collected in 1,2 and 4 hour after last induced. Aftergiving sodium nitrite 110 mg/kg bw and dimethylamine (1:5) orally for a week,N7-methylguanine and O6-methylguanine had not been detected in rat’s blood.
Removal of Mimosine from Leucaena leucocephala (Lam.) de Wit Seeds to Increase Their Benefits as Nutraceuticals Wardatun, Sri; Harahap, Yahdiana; Mun'im, Abdul; Saputri, Fadlina Chany, Dr.; Sutandyo, Noorwati
Pharmaceutical Sciences and Research Vol. 7, No. 3
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The Leucaena leucocephala (Lam.) de Wit tree contains pharmacologically active compounds and can easily be found in abundant quantities. The utilization of this tree as a source of nutraceuticals would increase its value. The extraction yields show the number of compounds that have been extracted by solvent. However, Leucaena leucocephala (Lam.) de Wit seeds also contain mimosine, which can cause hair loss. The present study investigated the process of removing mimosine from the seeds. Three treatments were applied to these seeds: treatment without soaking, soaking with distilled water for 24 hours, and splitting the seeds in half and then soaking with distilled water for 24 hours. The seeds were dried, ground, and then extracted with different concentrations of ethanol solvent. The mimosine levels of the extracts were measured with a JascoV-730 spectrophotometer using ferry chloride as a reagent. The results showed that the soaking process and the concentration of ethanol had significant effects on the extract yields and mimosine levels. The unsoaked seeds, extracted with 70% ethanol, produced the highest ratio of extract yield to mimosine level. Therefore, 70% ethanol can be used as a solvent to utilize unsoaked seeds as nutraceuticals.
Karakterisasi Gelatin Hasil Ekstraksi dari Kulit Ikan Patin (Pangasius hypophthalmus) dengan Proses Asam dan Basa Nasution, Azlaini Yus; Harmita, Harmita; Harahap, Yahdiana
Pharmaceutical Sciences and Research Vol. 5, No. 3
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Gelatin in the majority market comes from pigs and cows. The raw material of gelatin manufacture from other sources continue to be studied because it closely related with halal product. Currently gelatin from fish is an alternative to gelatin making. Catfish (Pangasius hypophthalmus) is a fish species developed in Kampar regency of Riau Province. The catfish skin can be used as raw material source in gelatin production. This study aims to compare the characteristics of gelatin extracted from catfish skin with acid and alkaline pretreatment. In the acid pretreatment, sulfuric acid is used until the solution at pH 3, then it is extracted with distilled water at 60ºC. In the alkaline pretreatment, the sample was added by 0.2 N NaOH followed by 0.05 N acetic acid and then extracted with distilled water at 60ºC. Characterizations done were including calculation of rendement value, organoleptic test, moisture content, pH, ash content, viscosity, gel strength and texture profile analysis using texture analyzer, protein content with Kjeldahl method and analysis amino acid with HPLC. Characterization of catfish gelatin with acid process gives the following results: rendement (14.94%), water content (9.80%), pH (5.14), ash (0.19%), viscosity (3.12 cP), protein content (97.71%), and highest amino acids, glycine = 16.90 %, proline = 11.08%, glutamic acid = 9.10 %. The result of gelatin characterizations with alkaline process: rendement (14.30%), water content (7.25%), and pH (5.35), ash content (1.54%), viscosity (5.35 cP), gel strength (141,5 g), protein content (91.92%), the highest amino acid content are glycine = 18.15%, proline = 12.30%, glutamic acid = 10.73%. Catfish gelatin through alkaline pretreatment exhibits better properties than acid pretreatment.
Validasi Metode Analisis Ofloksasin dalam Plasma In Vitro secara Kromatografi Cair Kinerja Tinggi-Fluoresensi Mengacu pada European Medicines Agency Guideline Tania, Letitia; Sitepu, Eme Stepani; Harahap, Yahdiana
Pharmaceutical Sciences and Research Vol. 3, No. 2
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Ofloxacin is an antibiotic from second generation of fluoroquinolones group. Concentration of ofloxacin in human plasma is in low level, and due to that fact, it requires a selective, accurate, sensitive method of analysis. In this study, the optimization and validation of ofloxacin analysis in human plasma using high performance liquid chromatography-fluorescence with ciprofloxacin-HCl as an internal standard were carried out. Separation of ofloxacin was performed using C18 (Waters, SunfireTM 5 µm; 250 x 4.6 mm) column with an isocratic mobile phase consisted of triethylamine 1% in water pH 3.0–acetonitrile (84:16) in the flow rate of 1.0 mL/min, 40oC column temperature whereas the detection was carried out at excitation of 300 nm and emission of 500 nm. Plasma extraction was done by deproteination using methanol, through the process of vortex and centrifugation (10000 rpm) for 2 minutes and 10 minutes consecutively. The method was valid and linear within the concentration ranged from 21,4 ng/mL to 4280 ng/mL with LLOQ of 21,4 ng/mL. Intra-day and inter-day accuracy and presicion was not more than + 20% for LLOQ and not more than + 15% for QCL, QCM, and QCH samples in both % diff and coefficient of variation. Ofloxacin was stable in human plasma at least three freeze and thaw cycle, for at least 24 hours in room temperature and 28 days at -20oC. This bioanalytical method fulfilled the acceptance criteria following EMEA guideline.
Chemical Properties, Biological Activities and Poisoning Treatment of Novichok: A Review Rahmania, Tesia Aisyah; Wardhani, Bantari Wisynu Kusuma; Renesteen, Editha; Harahap, Yahdiana
Pharmaceutical Sciences and Research Vol. 8, No. 2
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Novichok is an organophosphate compound found as a nerve agent chemical weapon. However, the information about its chemical properties, biological activities, and molecular interactions in the body are still protected under the “top secret” security clearance. Novichok, with the codes A230, A232 and A234, is a compound whose structure has been successfully determined. The compound is synthesized from a precursor through a nucleophilic substitution reaction. Novichok agents are considered more potent than VX gas and can be applied in unitary and binary forms. This compound has ability for the binding with acetylcholinesterase (AChE) due to inability of acetylcholine metabolism. AChE catalyzes the rapid hydrolysis of acetylcholine to acetate and choline. The treatment of Novichok agent poisoning is similar to management of other nerve agents, such as atropine and pralidoxime administered intravenously. In this paper, we reviewed the Novichok component from chemical and biological perspective. Moreover, we discussed the potential molecular interaction and treatment of this compound.
Transdermal Delivery of Ketoprofen for Osteoarthritis Treatment and Management: A Literature Review on Current Progression Ramadhani, Dwi Asih; Harahap, Yahdiana; Sagita, Erny; Permata Sari, Kartika Citra Dewi; Andranilla, Rr. Kirana; Trisina, Jessica; Punu, Gabriella Frederika; Ramadon, Delly
Pharmaceutical Sciences and Research Vol. 11, No. 1
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Arthritis, a diverse spectrum of joint disorders, is characterized by chronic pain and inflammation. Osteoarthritis (OA), the most prevalent form, leads to disabling pain, functional limitations, and reduced mobility. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for managing OA pain, with ketoprofen recognized as one of the effective options. However, oral administration of ketoprofen may cause gastrointestinal irritation. Addressing this issue, Transdermal Drug Delivery Systems (TDDS) emerge as a promising alternative route of administration. TDDS facilitates delivery of various drugs through the skin without undergoing first-pass metabolism. Recent studies have centered on enhancing ketoprofen’s transdermal delivery, particularly focusing on different methods (such as patches, gels, electroporation technology, and stratum corneum bypass methods), with microneedles emerging as a promising approach for delivering anti-inflammatory drugs through transdermal routes. This review aims to explore recent advancements in transdermal drug delivery systems for managing OA. The utilization of transdermal ketoprofen presents innovative opportunities for future research and development in novel drug delivery systems.
Reaksi Merugikan Obat Kanker Berbasis Antrasiklin pada Pasien Kanker Payudara di RS Kanker Dharmais Chairunnisa, Dian Fitri; Harahap, Yahdiana; Syafhan, Nadia Farhanah; Purwanto, Denni Joko
JFIOnline | Print ISSN 1412-1107 | e-ISSN 2355-696X Vol. 16 No. 1 (2024): Jurnal Farmasi Indonesia
Publisher : Pengurus Pusat Ikatan Apoteker Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.35617/jfionline.v16i1.164

Abstract

Breast cancer is the type of cancer that most often affects women worldwide. Doxorubicin is an anthracycline class, a first-line anticancer therapy with clinical activity in breast cancer. Doxorubicin can cause cardiotoxic effects due to the formation of doxorubicinol as its primary metabolite. Adverse drug reactions also vary depending on the chemotherapy regimen. This study aimed to determine the adverse reactions to anthracycline-based drugs that breast cancer patients often experience. This observational descriptive study was conducted from April to July 2022 at the Dharmais Cancer Hospital, Jakarta. The sample in this study was breast cancer patients undergoing chemotherapy with anthracycline-based regimens. Data were collected through interviews and observation of medical records, which were analyzed by univariate analysis. The results showed that the most frequent drug reaction was alopecia, with a percentage of 97.1%. They were followed by nausea at 85.7%, vomiting at 71.4% and pain at 65.7%. The fastest time for nausea to appear is within 18-24 hours (peak days 2 to 3) after chemotherapy. Did not experience a decrease in left ventricular ejection fraction by 34.3%, and 65.7% experienced a reduction in left ventricular ejection fraction after doxorubicin chemotherapy. Patients who underwent a reduction in left ventricular ejection fraction after doxorubicin chemotherapy had a decrease in ejection fraction <10%, and no patients experienced a decline in left ventricular ejection fraction >10%. Breast cancer patients who receive anthracycline-based treatment can experience adverse drug reactions, including nausea, vomiting, alopecia, pain and decreased left ventricular ejection fraction.
Co-Authors . Harmita . Hayun . Hayun Achmad Noerkhaerin Putra Aldrat, Hendri Aldrat, Hendri Andranilla, Rr. Kirana Ani Susanti Ani Susanti Anjani, Qonita Kurnia Baitha Palanggatan Maggadani, Baitha Palanggatan Bambang Karsono Binsar Simanjuntak Binsar Simanjuntak, Binsar Chairunnisa, Dian Fitri Christine Estherina Christine Estherina, Christine Citra Nur Azizah Citra Nur Azizah, Citra Nur Cosphiadi Irawan Dadang Kusmana DENNI JOKO PURWANTO, DENNI JOKO Dewi, Dian Andriani Ratna Donnelly, Ryan F. Erilia Kesumahati Erny Sagita, Erny Fadlina Chany Saputri Handayani, Raden Rara Diah Hanifah, Muthia Harefa, Faonaso Harmita Harmita Harmita Harmita, Harmita Harryanto Reksodiputro, Harryanto Harsono, Cecilia F. Hartrianti, Pietradewi Hayun Hayun Hayun Hayun Heffen, Wan Lelly Heffen, Wan Lelly Herman Suryadi Indah Widyaningsih Isra, Nur Krismartina, Mirna Krismartina, Mirna Letitia Tania, Letitia Loedfiasfiati Alawiyah Maksum Radji Mardhiani, Rizka Maryati Kurniadi Mun'im, Abdul Nadia Farhanah Syafhan Nasution, Azlaini Yus Noorwati Sutandyo Nu Alia Nu Alia, Nu Nurrobi, R.M. Tjahya Permata Sari, Kartika Citra Dewi Pridilla, Asmiladita Punu, Gabriella F. Punu, Gabriella Frederika Rahmania, Tesia Aisyah Ramadhani, Dwi Asih RAMADON, DELLY Renesteen, Editha Santi Purna Sari Sherly Meilianti Sherly Meilianti, Sherly Sitepu, Eme Stepani Sri Wardatun Sunarsih Sutanto Theresia Sinandang Theresia Sinandang, Theresia Trisina, Jessica Umar Mansur Umar Mansur Umar Mansur, Umar Wan Lelly H Wardhani, Bantari Wisynu Kusuma Winnugroho Wiratman