{"title":"Analysis of Residual Solvents-Impurities by HS-GC-FID: Case of Seven Samples of Ciprofloxacin API.","authors":"Derouicha Matmour","doi":"10.52794/hujpharm.1098619","DOIUrl":"https://doi.org/10.52794/hujpharm.1098619","url":null,"abstract":"Residual solvents are organic volatile impurities that can occur in the manufacture of Active Pharmaceutical Ingredients (APIs). Residual solvents analysis in pharmaceutical products is necessary not only because of they represent a potential risk for human health due to their toxicity and their undesirables side effects, but also because they may affect the physicochemical proprieties of pharmaceutical product. The main objective of this work was to analysis 29 residual solvents-impurities by Head Space Gas Chromatography with Flame Ionization Detector (HS-GC-FID) in seven samples of Ciprofloxacin Hydrochloride API, collected from seven pharmaceutical industries installed in Algeria. The GC was equipped with a flame-ionization detector and silica column coated with 1.8 µm layer of phase G43. The carrier gas was helium with a linear velocity of 35 cm/s and a split ratio of 1:5. The column temperature was 40 °C then it rised to 240 °C. The injection temperature was 140 °C and that of detector was 250 °C. Twenty-nine organic solvents belong to classes 1 and 2 were analyzed in seven samples of Ciprofloxacin Hydrochloride API whose control is mandatory because of their carcinogenic and intrinsic toxicity. Only five solvents were identified wich are Hexane, Toluene, Acetonitrile, Methanol and Dichloromethane in the different samples. All samples collected satisfied the test of identification, so, the confirmation and the quantification procedures weren’t realized. The HS-GC-FID technique used showed that the identified solvents differ from one sample to another of the same molecule. This showed that manufacturers didn’t often use the same solvents to produce the same API, which justifies that residual organic solvent tests weren’t usually mentioned in the specific monographs.","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"525 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83571730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Ameliorating Potential of Marketed Formulations Containing Prebiotics And Probiotics Against Carbon Tetrachloride-Induced Hepatotoxicity in rats","authors":"Dr Gopi Shah","doi":"10.52794/hujpharm.1134688","DOIUrl":"https://doi.org/10.52794/hujpharm.1134688","url":null,"abstract":"In the present work, two marketed formulations VELGUT® (combination of prebiotic and probiotics) and VIZYLAC® (probiotic only) were assessed for a protective effect against carbon tetrachloride-induced chronic liver injury model in rats. Rats were randomly divided into four groups. Normal Control (treated with normal saline) and CCl4 treated group (treated with 1 ml/kg intraperitoneal injection of CCl4 once daily for 10 days followed by twice a week up to 49 days). Test groups composed of the oral treatment of VELGUT (1 mg kg-1) along with CCl4 (T1) and oral treatment of VIZYLAC (4 mg kg-1) along with CCl4. CCl4 treatment in the test group was similar to group 2. At the end of the treatment, various serum biochemical parameters like Alanine aminotransferase (ALT), Aspartate Aminotransferase, (AST), Alkaline Phosphatase (ALP), direct bilirubin, total protein, and albumin levels were measured. Serum cholesterol, glucose and malondialdehyde (MDA) levels were also measured. A small piece of the liver was collected to perform histopathological studies. Serum AST, ALT, ALP, and direct bilirubin were found to be significantly lower as compared to CCl4 intoxicated rats. The level of total protein and albumin was improved. The level of MDA, glucose and cholesterol was improved as compared to CCl4 treated group.","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"110 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87697488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Determination of Multi-Elemental Analysis and Antioxidant Activities of Helichrysum arenarium (L.) Moench Species","authors":"Adil Umaz, Kader Umaz, F. Aydin, I. Aydin","doi":"10.52794/hujpharm.1118558","DOIUrl":"https://doi.org/10.52794/hujpharm.1118558","url":null,"abstract":"In this study, multi-elemental analysis and antioxidant activity of samples belonging to different locations of Helichrysum arenarium (L.) Moench known as the immortal flower was determined. The results obtained were compared within themselves. The Ca, Mg, Al, Fe, Na, Li, Be, B, Ti, Cr, Ni, Zn, Mo, and Pb element contents of the sample belonging to the B location were determined that were higher than that of the other location. The K, V, Mn, Co, Cu, As, Se, Sn, and Ba element contents of the sample belonging to the G location were determined that were higher than that of the other location. When the antioxidant activity results of the species were evaluated; according to the CUPRAC (Cupric Reducing Antioxidant Capacity) method, the sample extracts of the B and G locations were determined that showed lower activity than the standard BHA, BHT, and Trolox values at 20 and 40 µg/mL concentrations, and showed close activity compared to the standards at 80 µg/mL concentrations. The species was determined that be antioxidant activity even at low concentrations. According to the DPPH (2,2-difenil-1-pikrilhidrazil) method, the antioxidant activity of the extract of the B and G locations was determined as 22.95 and 23.76 mg TE/mL, respectively. According to the results of the bivariate analysis of the species; considering the p < 0.01 and 0.05 confidence level of the sample belonging to the B location, it was determined that the strongest correlation was between Na and Al (r = -0.888), and the strongest correlation of the sample belonging to the G location was between Al and B (r = 0.844).","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84658261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Kozmesötik Uygulama için Galaxaura rugosa (J. Ellis & Solander) J.V. Lamouroux: Antioksidan, Antibakteriyel, Tirozinaz ve Elastaz Engelleme Özellikleri","authors":"Eldrin Arguelles","doi":"10.52794/hujpharm.1064820","DOIUrl":"https://doi.org/10.52794/hujpharm.1064820","url":null,"abstract":"Kırmızı deniz yosunları, ilaç sentezi için kullanılabilecek çeşitli biyolojik aktivitelere sahip yeni doğal ürün kaynakları olarak kabul edilir. Kırmızı makroalg, Galaxaura rugosa'nın biyoaktif özellikleri araştırıldı. Sonuçlar, makroalg'in 12.11 ± 0.22 mg GAE/g toplam fenolik içerik (TPC) içerdiğini gösterdi. G. rugosa'nın antioksidan aktivitesi, güçlü ABTS+ radikal süpürme aktivitesi (IC50 = 81.00 μg GAE/ml) ve yüksek bakır indirgeme kapasitesi (IC50 = 19.26 μg GAE/ml) sergiledi. G. rugosa ekstraktının tirozinaz ve elastaz inhibisyon özelliklerinin değerlendirilmesi, alg'in sırasıyla 88,00 μg GAE/ml IC50 ve 243,00 μg GAE/ml IC50 ile etkili inhibitör aktiviteye sahip olduğunu göstermiştir, bunlar kojik asit ve tokoferolden daha etkilidir. Deniz yosunu özütü, Staphylococcus aureus (Minimum İnhibitör Konsantrasyon (MIC) = 125 μg/ml), Metisiline dirençli Staphylococcus aureus (MIC = 125 μg/ml) ve Staphylococcus epidermidis (MIC = 250) gibi yaygın bakteriyel cilt patojenlerine karşı güçlü antibakteriyel aktiviteler sergilemiştir. μg/ml). Bu çalışma, G. rugosa'nın kozmetik uygulama potansiyelini gösteren öncü bir araştırma olarak kabul edilmektedir.","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"267 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73359327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Incompatibility Studies of Tamsulosin HCl using TGA, DSC and FT-IR","authors":"A. Shrivastava, Ashu Mittal","doi":"10.52794/hujpharm.1092728","DOIUrl":"https://doi.org/10.52794/hujpharm.1092728","url":null,"abstract":"The Benign Prostatic Hyperplasia is one of the common old age problem and alpha one adrenoreceptor blockers are commonly used for symptomatic relief. Tamsulosin HCl is selective alpha 1A adrenoreceptor blocker with better tolerability profile and once daily dosing advantage. The present study was under taken to establish the compatibility of Tamsulosin with a number of commonly used excipients by using thermo analytical technique viz Thermogravimetry (TG) and differential scanning calorimetry (DSC) used in formulation. The TG and DSC both results demonstrated that ethyl cellulose, Gelatin and lactose found to be incompatible with Tamsulosin and should be avoided for the pharmaceutical preparation.","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91033507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
F. Yerlikaya, Aslıhan Arslan, Özlem Ati̇k, Seda Kozan, Ahmet Parlak, Meltem ÖZEL KARATAŞ, Onur Saglam, S. P. Aytaç
{"title":"The Bioequivalence Study of Two Cefdinir 250 mg/5 mL Oral Suspension Formulations in Healthy Males Under Fasting Conditions","authors":"F. Yerlikaya, Aslıhan Arslan, Özlem Ati̇k, Seda Kozan, Ahmet Parlak, Meltem ÖZEL KARATAŞ, Onur Saglam, S. P. Aytaç","doi":"10.52794/hujpharm.1103650","DOIUrl":"https://doi.org/10.52794/hujpharm.1103650","url":null,"abstract":"A new liquid oral formulation of cefdinir has been developed and a bioequivalence study was conducted. This single-center study was designed as an open-label, randomized, two-period, cross-over trial, and was performed with healthy males under fasting conditions in compliance with Good Clinical Practice (GCP) principles. Two 250 mg/5mL suspension formulation of cefdinir was compared in terms of their pharmacokinetic properties and the bioequivalence of the new formulation was assessed according to the requirement of the authorities. The blood samples of the volunteers were taken at certain points specified to cefdinir, to evaluate the plasma concentrations and pharmacokinetic properties of two cefdinir formulations by using a validated LC-MS/MS analytical method. The bioequivalence of the new formulation has been shown and the tolerability of both products was acceptable.","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82187954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Melatonin prevented depressive-like behavior following cyclosporine A or interferon-α administration in mice","authors":"A. Mesripour, Mahdi Aghamohseni̇","doi":"10.52794/hujpharm.1061875","DOIUrl":"https://doi.org/10.52794/hujpharm.1061875","url":null,"abstract":"Background: Cyclosporine A (CYA) prevents graft rejection after transplantation, interferon-α (IFN-α ) is a natural cytokine prescribed in some types of malignancies and hepatitis C virus. However neurologic complication such as depression is a side effect of chronic use of these drugs. Melatonin apart from its effect on regulating the circadian rhythm, has a potent antioxidant effect and inhibits N-methyl-d-aspartic acid (NMDA) current. The goal was to evaluate the antidepressant effect of melatonin following IFN-α, and CYA administration in mice. Methods: Male NMRI mice (25-30 g) were used, IFN-α (1600000 IU/kg, sc), CYA (20 mg/kg, ip), melatonin (50 mg/kg, ip), and fluoxetine (20 mg/kg, ip) were administered daily. After evaluating the locomotor activity, depression was assessed by splash test, forced swimming test (FST), and the sucrose preference test. Results: While there was no significant difference in locomotor activity amongest different anamal groups, following melatonin pretreatment with IFN-α immobility time in FST significantly reduced (58.50±19.4s, p","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"53 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83633986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Vincetoxicum hirundinaria'nın Farklı Kısımlarının Bazı Biyolojik Aktiviteleri","authors":"Zehra Öksüz, Sevda Güzel","doi":"10.52794/hujpharm.1128462","DOIUrl":"https://doi.org/10.52794/hujpharm.1128462","url":null,"abstract":"In this study, it was aimed to determine the antimicrobial, antibiofilm activities and synergistic effects of ethanol extracts obtained from above-ground, root, seed and seed coat of Vincetoxicum hirundinaria Medic. Antimicrobial activity was performed against 7 bacterial and 3 fungal standard strains by microdilution method and minimum inhibition concentrations (MIC) were determined. The crystal violet method was applied to determine the prevention of biofilm formation and inhibition of preformed biofilm activities on P. aeruginosa biofilm. In addition, the synergistic effects of aerial part and seed extracts against both E. coli and E. faecalis were examined by the microdilution checkerboard method. According to the antimicrobial test results tested extracts had moderate to low efficacy against studied bacterial and yeast strains. The synergy test showed that the aerial and seed extracts had additive effect against both E. coli and E. faecalis. The extracts also showed the potential to inhibit biofilm formation and inhibit preformed biofilms. Root and seed pod extracts showed the strongest antibiofilm activity, while the aerial part extract was the weakest. In conclusion, our results prove that the tested extracts, especially obtained from root and seed pods and used in the treatment of many diseases, have potential in terms of antibiofilm activity. The literature search indicated that the antimicrobial and antibiofilm activities of V. hirundinaria was evaluated for the first time in the current study, therefore; our findings provide important preliminary data to the literature in terms of antibiofilm activity of V. hirundinaria","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"159 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76623778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lusiani Tjandra, Budhi Seti̇awan, Kartika Ishartadi̇ati̇, Sri Utami̇
{"title":"Fermente Soya Fasulyesi Ekstresinin Mycobacterium Tuberculosis ile Enfekte Rattus Norvegicus Arasında Pro İnflamatuvar Sitokinler Üzerindeki Etkisi","authors":"Lusiani Tjandra, Budhi Seti̇awan, Kartika Ishartadi̇ati̇, Sri Utami̇","doi":"10.52794/hujpharm.1045534","DOIUrl":"https://doi.org/10.52794/hujpharm.1045534","url":null,"abstract":"Çalışma, Mycobacterium tuberculosis enfeksiyonundan sonra erkek Wistar sıçanları arasında proinflamatuar sitokinler üzerinde etanolik ekstrakt tempeh sağlanmasının etkinliğini değerlendirmeyi amaçladı. Randomize, test sonrası kontrollü bir tasarım, tüberkülozla enfekte olmuş sıçanları kullandı. Birinci, ikinci ve üçüncü gruplar, sırasıyla 200, 400 ve 800 mg/kg vücut ağırlığı konsantrasyonlarında ekstrakt tempeh takviyesi aldı. Dördüncü grup, kontrol grubu olarak Karboksimetil Selüloz Sodyum aldı ve beşinci gruptaki sıçanlar, histopatoloji analizleri kullanılarak TB varlığını doğrulamak için kurban edilecekti. Tümör nekroz faktörü-alfa (TNF a), interferon gama (INF ɣ) ve interlökin (IL)-2, IL-6, IL-10 ve IL-12, enzime bağlı immünosorbent deney yöntemiyle ölçüldü. Kontrol grubu ile karşılaştırıldığında tüm konsantrasyonlarda TNF a, IL-2, IL-6, IL-10 ve IL-2 seviyelerinde önemli farklılıklar yoktu. 800 mg/kg vücut ağırlığı takviyesi konsantrasyonunda, IFN-ɣ seviyesi kontrolden önemli ölçüde düşüktü (p = 0.0047). Etanolik tempeh özütünün takviyesi, pozitif bir etki göstermedi ve hayvan tüberküloz modelinde proinflamatuar sitokinler üzerinde zayıf etkinlik tanımladı.","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83687669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Esraa Elhadi̇, Leena Abdulazi̇z, Ejlal A. A. Abdallah, Fadlalbaseer Alamin Eltieb Alnoor Alnoor, Bashir A. Yousef
{"title":"Onaylanmış Merkezi Etkili İlaçların Antiviral Aktivitesi: Bir Anlatı İncelemesi","authors":"Esraa Elhadi̇, Leena Abdulazi̇z, Ejlal A. A. Abdallah, Fadlalbaseer Alamin Eltieb Alnoor Alnoor, Bashir A. Yousef","doi":"10.52794/hujpharm.1047842","DOIUrl":"https://doi.org/10.52794/hujpharm.1047842","url":null,"abstract":"Viral enfeksiyonların ortaya çıkması ve yeniden ortaya çıkması, birçoğunun sinir sistemini etkilediği ciddi sorunları temsil eder; bu viral enfeksiyonların birçoğunun hala etkili bir aşı veya tedavisi yoktur, bu nedenle de novo ilaç keşfi yaklaşımı ile birlikte ilacı yeniden tasarlama yaklaşımının dikkate alınması ve başarılı aşıların bulunması bu enfeksiyonların üstesinden gelme çabalarını destekleyecektir. İlacın yeniden kullanım amacına yönelik yaklaşımı ile ilgili olarak, sinir sistemi üzerindeki etkileri onaylanmış ve antiviral aktivite sergileyen ilaçlar, kan-beyin bariyerini geçebilme ve sinir sistemine kolayca ulaşabilme avantajına sahip olarak, yeniden kullanım için umut verici adaylar sunmaktadır. Viral enfeksiyonların üstesinden gelme çabasında yer alan bu anlatı inceleme makalesi, başlangıçta sinir sistemi üzerindeki etkileri için onaylanmış ilaçların antiviral aktivitesine odaklanan araştırmaları özetlemekte ve bulgular viral aile grubuna göre bölümler halinde düzenlenmiştir. Diğer araştırmacılara ilaçların aynı ailenin üyeleri üzerindeki etkisi ile farklı viral ailelerin virüsleri üzerindeki etkisi arasında ilişki kurmasına yardımcı olmak için çalışmalarda kullanılan virüsler.","PeriodicalId":39138,"journal":{"name":"Hacettepe University Journal of the Faculty of Pharmacy","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75105944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}