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Journal of pharmaceutical analysis 2024年第4期14卷 615-618页

作者： Yue Liu Mengjia Li Xing Fu Yi Zhang Ce Tang State Key Laboratory of Southwestern Chinese Medicine Resources School of Ethnic MedicineChengdu University of Traditional Chinese MedicineChengdu611137China Meishan Hospital of Chengdu University of Traditional Chinese Medicine MeishanSichuan620010China Innovative Institute of Chinese Medicine and pharmacy Chengdu University of Traditional Chinese MedicineChengdu611137China

The dried roots of Aconitum pendulum Busch are the major source of a commonly used Tibetan medicine,namely Tiebangchui(TBC)(Fig.S1).However,raw TBC contains a large amount of high toxic diester-diterpenoid alkaloids(DDAs),and the improper use would cause arrhythmia,irreversible cardiovascular damages,and even death.“Paozhi”,an appropriate processing method,is the essential prerequisite for the safe clinical application of ***-decocting and sand-frying are commonly used processing methods for toxicity attenuation and efficacy preservation for TBC.

关键词： dried irreversible roots

LC and LC–MS/MS studies for the identification and characterization of degradation products of acebutolol

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Journal of pharmaceutical analysis 2018年第6期8卷 357-365页

作者： Uday Rakibe Ravi Tiwari Anand Mahajan Vipul Rane Pravin Wakte department of Chemical Technology Dr.Babasaheb Ambedkar Marathwada University department of pharmaceutical Sciences SVKM's NMIMS department of pharmaceutical analysis Goa College of Pharmacy

The aim of the present investigation was to demonstrate an approach involving use of liquid chromatography(LC) and liquid chromatography-mass spectrometry(LC–MS) to separate, identify and characterize very small quantities of degradation products(DPs) of acebutolol without their isolation from the reaction mixtures. The drug was subjected to oxidative, hydrolytic, thermal and photolytic stress conditions as per International Conference on Harmonization(ICH) guideline Q1 A(R2). Among all the stress conditions the drug was found to be labile in hydrolytic(acidic & basic) and photolytic stress conditions, while it was stable in water-induced hydrolysis, oxidative and thermal stress conditions. A total of four degradation products were formed. A C18 column was employed for the separation of all the DPs on a gradient mode by using high-performance liquid chromatography(HPLC). All the DPs were characterized with the help of their fragmentation pattern and the masses obtained upon LC–MS/MS and MSnanalysis. All the hitherto unknown degradation products were identified as 1-(2-(2-hydroxy-3-(isopropylamino)propoxy)-5-(amino)phenyl)ethanone(DP-I), N-(4-(2-hydroxy-3-(isopropylamino)propoxy)-3-acetylphenyl)acrylamide(DP-II), 1-(2-(2-hydroxy-3-(isopropylamino)propoxy)-5-(hydroxymethylamino)phenyl)ethanone(DP-III) and 1-(6-(2-hydroxy-3-(isopropylamino)propoxy)-2,3-dihydro-2-propylbenzo[d]oxazol-5-yl)ethanone(DP-IV). Finally the in-silico carcinogenicity and hepatotoxicity predictions of the drug and all the DPs were performed by using toxicity prediction softwares viz., TOPKAT, LAZAR and Discovery Studio ADMET. The results of in-silico toxicity studies revealed that acebutolol(0.967) and DP-I(0.986) were found to be carcinogenic, while acebutolol(0.490) and DP-IV(0.437) were found to be hepatotoxic.

关键词： Acebutolol Stress testing LC LC–MS/MS Degradation pathway In-silico toxicity

LC-MS/MS analysis and pharmacokinetic study on five bioactive constituents of Tanreqing injection in rats

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Chinese Journal of Natural Medicines 2016年第10期14卷 769-775页

作者： ZHANG Feng SUN Liang GAO Shou-Hong CHEN Wan-Sheng CHAI Yi-Feng department of pharmacy Changzheng HospitalSecond Military Medical University department of pharmaceutical analysis School of Pharmacy Second Military Medical University department of pharmacy The 98th Hospital of PLA

Tanreqing injection(TRQ), a well-known traditional Chinese medicine formula, is commonly used to treat respiratory diseases. In the present study, a rapid, selective, and sensitive liquid chromatography-tandem mass spectrometry(LC-MS/MS) method was developed and validated to simultaneously determinate the plasma contents of 5 major constituents of TRQ, including chlorogenic acid(CHA), caffeic acid(CFA), baicalin(BA), ursodeoxycholic acid(UDCA) and chenodeoxycholic acid(CDCA) in rats after intravenous administration of TRQ. Chromatographic separation was performed on an Agilent Zorbax SB-C_(18) column(3.5 μm, 100 mm × 2.1 mm), with acetonitrile and 0.1% aqueous formic acid as mobile phase at a flow rate of 0.3 m L·min^(^(-1)). The calibration curves were linear over the ranges of 27.0–13 333.0 ng·m L^(-1) for CFA, 30.0–14 933.0 ng·m L^(-1) for CHA, 50.0–50 333.0 ng·m L^(-1) for BA, 550.0–55 000.0 ng·m L^(-1) for UDCA, and 480.0–48 000.0 ng·m L^(-1) for CDCA, respectively. Intra- and inter-day precisions(relative standard deviations, RSDs) were from 3.11% to 14.08%. The extraction recoveries were greater than 71% and accuracy(relative recovery) was from 89% to 137% for all analytes, except endogenous bile acids. This validated method was successfully applied to the first pharmacokinetic study of CFA, CHA, BA, UDCA and CDCA in rat plasma after intravenous administration of TRQ.

关键词： Tanreqing Injection Flavones Phenolic acids Bile acids Pharmacokinetics

Efficacy and safety of pharmacotherapeutic interventions used in visceral leishmaniasis clinical trials:A systematic review and network meta-analysis

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Asian Pacific Journal of Tropical Medicine 2022年第8期15卷 343-353,I0001-I0010页

作者： Aamir Bashir Gautam Sahu Ishfaq Rashid Pramil Tiwari department of pharmacy Practice National Institute of Pharmaceutical Education and ResearchS.A.S.Nagar Mohali160062PunjabIndia

Objective:To compare the efficacy and safety outcomes of different antileishmanial agents used in visceral leishmaniasis clinical ***:A systematic literature search in PubMed/MEDLINE,EMBASE,Cochrane,and Google Scholar was done using keywords“randomized controlled trials”,“antileishmanial”and“visceral leishmaniasis”.The outcomes included were cure rate,overall withdrawals,relapse rate,and treatment-emergent adverse *** estimates through the frequentist network meta-analysis approach were presented as OR with 95%*** plots were used for identifying the“best intervention”based on p-scores obtained using the surface under the cumulative *** risk of bias was evaluated by using Pedro ***:Seventeen randomized controlled trials with 5143 visceral leishmaniasis patients who received different antileishmanial agents(amphotericin B,miltefosine,paromomycin,meglumine antimoniate,sodium stibogluconate,sitamaquine,and pentavalent antimonials)and met the inclusion criteria were *** efficacy outcomes of the treatments,the rankogram of the network meta-analysis revealed that paromomycin(p-score=0.8148)has the highest probability of being best in the pool,followed by sodium stibogluconate(OR 0.82,95%CI 0.24-2.79,p-score=0.7580),amphotericin B+miltefosine(OR 0.66,95%CI 0.02-19.04,p-score=0.7329)as compared to the remaining treatments;however,the most of the treatment-emergent adverse events were reported with ***:Paromomycin reported the highest cure rates,while the maximum treatment-emergent adverse events were seen with sitamaquine.

关键词： Visceral leishmaniasis Treatment Efficacy Safety Network meta-analysis

Preparation of Magnetic Molecularly Imprinted Polymers for Selective Isolation and Determination of Kaempferol and Protoapigenone in Macrothelypteris torresiana

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Journal of Huazhong University of Science and Technology(Medical Sciences) 2014年第6期34卷 845-855页

作者：蔡培珊赵洋杨通华陈静熊朝梅阮金兰 department of pharmaceutical analysis School of Pharmacy Tongji Medical College Huazhong University of Science and Technology

Novel uniform-sized magnetic molecularly imprinted polymers （MMIPs） were synthe- sized for selective recognition of active antitumor ingredients of kaempferol （KMF） and protoapi- genone （PA） in Macrothelypteris torresiana （M. torresiana） by surface molecular imprinting tech- nique in this study. Super paramagnetic core-sheU nanoparticles （γ-MPS-SiO2@Fe3O4） were used as seeds, KMF as template molecule, acrylamide （AM） as functional monomer, and N, N＇-methylene bisacrylamide （BisAM） as cross-linker. The prepared MMIPs were characterized by X-ray diffraction （XRD）, Fourier transform infrared spectrum fiT/R）, transmission electron microscopy （TEM） and thermo-gravimetric analysis （TGA）, respectively. The recognition capacity of MMIPs was 2.436 times of non-imprinted polymers. The adsorption results based on kinetics and isotherm analysis were in accordance with the pseudo-second-order model （R2=0.9980） and the Langmuir adsorption model （R2=0.9944）. The value of E （6.742 kJ/mol） calculated from the Dubinin-Radushkevich isotherm model suggested that the physical adsorption via hydrogen-bonding might be predominant. The Scatchard plot showed a single line （R2=0.9172） and demonstrated the homogeneous recognition sites on MMIPs for KMF. The magnetic solid phase extraction （MSPE） based on MMIPs as sorbent was established for fast and selective enrichment of KMF and its structural analogue PA from the crude extract of M. torresiana and then KMF and PA were detected by HPLC-UV. The established method showed good performance and satisfactory results for real sample analysis. It also showed the feasi- bility of MMIPs for selective recognition of active structural analogues from complex herbal extracts.

关键词： magnetic molecularly imprinted polymers magnetic solid phase extraction kaempferol protoapigenone Maerothelypteris torresiana

Phytochemical analysis and Antioxidant Activity of Crocus speciosus Leaves

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Phyton-International Journal of Experimental Botany 2022年第1期91卷 207-221页

作者： Olha Mykhailenko Ivan Bezruk Victoriia Volochai Volodymyr Mishchenko Liudas Ivanauskas Victoriya Georgiyants department of pharmaceutical Chemistry National University of PharmacyKharkiv61168Ukraine department of Pharmacognosy National University of PharmacyKharkiv61168Ukraine department of Quality Standardisation and Certification of DrugsNational University of PharmacyKharkiv61001Ukraine department of Analytical and Toxicological Chemistry Lithuanian University of Health SciencesKaunas44307Lithuania

The numerous studies indicate leaves of plants are a rich source of bioactive compounds that can be a valuable source of compounds used in the pharmaceutical and cosmetic *** of this study was to investigate the chemical composition and the antioxidant property of Crocus speciosus *** phytochemical screening of *** leaves revealed the presence of some following compound categories such as phenolic compounds,aminoacids,saponins,proteins,tannins,triterpenoids,glycosides,*** total flavonoids and phenolic compounds content were determined spectrophotometrically and by HPLC-DAD and *** activity was determined by ABTS radical-cation scavenging method,*** total amount of flavonoids in *** leaves was 1.07±0.02 mg RE/g(panalysis the presence of the mangiferin,chlorogenic acid,isoorientin,kaempferol,hyperoside,and isoquercitin was established for the first time in Crocus *** antiradical activity of *** leaves extracts was 150.08±4.5μmol/g(p<0.05)and its was mainly attributed to phenolic compounds *** high amounts of flavonoids and antiradical activity in *** leaves suggests promising phytochemical and pharmacological study of this Crocus species.

关键词： Crocus speciosus flavonoids leaves antiradical activity

Novel approaches in search for biomarkers of cholangiocarcinoma

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World Journal of Gastroenterology 2022年第15期28卷 1508-1525页

作者： Lavinia-Patricia Mocan Maria Ilieș Carmen Stanca Melincovici Mihaela Spârchez RareșCrăciun Iuliana Nenu Adelina Horhat Cristian Tefas Zeno Spârchez Cristina Adela Iuga Tudor Mocan Carmen Mihaela Mihu department of Histology Faculty of Medicine"Iuliu Hațieganu"University of Medicine and PharmacyCluj-Napoca 400012Romania department of Proteomics and Metabolomics MedFUTURE Research Center for Advanced Medicine"Iuliu Hațieganu"University of Medicine and PharmacyCluj-Napoca 400349Romania ^(nd)Pediatrics department Faculty of Medicine"Iuliu Hațieganu"University of Medicine and PharmacyCluj-Napoca 400012Romania ^(rd)Medical department Faculty of Medicine"Iuliu Hațieganu"University of Medicine and PharmacyCluj-Napoca 400012Romania department of Gastroenterology "Prof.dr.Octavian Fodor"Institute for Gastroenterology and HepatologyCluj-Napoca 400162Romania department of pharmaceutical analysis Faculty of Pharmacy"Iuliu Hațieganu"University of Medicine and PharmacyCluj-Napoca 400012Romania

Cholangiocarcinoma(CCA)arises from the ductular epithelium of the biliary tree,either within the liver(intrahepatic CCA)or more commonly from the extrahepatic bile ducts(extrahepatic CCA).This disease has a poor prognosis and a growing worldwide *** poor outcomes of CCA are partially explained by the fact that a final diagnosis is challenging,especially the differential diagnosis between hepatocellular carcinoma and intrahepatic CCA,or distal CCA and pancreatic head *** patients present with an advanced disease,unresectable disease,and there is a lack in non-surgical therapeutic *** least,there is an acute lack of prognostic biomarkers which further complicates disease ***,there is a dire need to find alternative diagnostic and follow-up pathways that can lead to an accurate result,either singlehandedly or combined with other *** the"-omics"era,this goal can be attained by various means,as it has been successfully demonstrated in other primary *** variants can reach a biomarker status ranging from circulating nucleic acids to proteins,metabolites,extracellular vesicles,and ultimately circulating tumor ***,given the relatively heterogeneous data,extracting clinical meaning from the inconsequential noise might become a tall *** current review aims to navigate the nascent waters of the non-invasive approach to CCA and provide an evidence-based input to aid clinical decisions and provide grounds for future research.

关键词： Cholangiocarcinoma Biomarker Proteomics Metabolomics Extracellular vesicles Circulating nucleic acids

Application of RP-HPLC method in dissolution testing and statistical evaluation by NASSAM for simultaneous estimation of tertiary combined dosages forms

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Journal of pharmaceutical analysis 2015年第5期5卷 307-315页

作者： Yogesh Upadhyay Nitin Sharma G.S.Sarma Ravindra K.Rawal department of pharmaceutical analysis Indo-Soviet Friendship College of Pharmacy

A dissolution method with robust high performance liquid chromatographic （HPLC） analysis for im- mediate release tablet formulation was developed and validated to meet the requirement as per Inter- national Conference on Harmonization （ICH） and United States Food and Drug Administration （USFDA） guidelines. The method involved the use of Agilent ZORBAX Eclipse XDB C18 column, and temperature was maintained at 30 ℃. After optimization, the mobile phase was selected as phosphate buffer （KH2PO4, 30 mM）： ACN （60：40, v/v） with pH 3.0, and retention time Rt was found as 3.24, 4.16, and 2.55 min for paracetamol （PCM）, chlorpheniramine maleate （CPM） and phenylephrine hydrochloride （PH） respec- tively at 265 nm and at a flow rate of 1 mL/min. The relative standard deviation （%RSD） for 6 replicate measurements was found to be less than 2%. Furthermore net analyte signal standard addition method （NASSAM） with spectrophotometer was performed for standard and liquid oral suspension. On the basis of selectivity, sensitivity and accuracy analysis, it was confirmed that this novel method could be useful for simultaneous estimation of the given drug combinations. Two-way analysis of variance （ANOVA） was applied for evaluating the statistical difference between the assay results obtained via both NASSAM and RP-HPLC methods and ultimately no significant difference was found between both the methods. All the methods and results were acceptable and confirmed that the method was suitable for intended use.

关键词： DissolutionRP-HPLCNet analyte signal standard addition meth-odTwo-way ANOVA

Stability-indicating liquid chromatographic method for the determination of Letrozole in pharmaceutical formulations

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Journal of pharmaceutical analysis 2012年第4期2卷 298-305页

作者： M.Mathrusri Annapurna Chitaranjan Mohapatro A.Narendra department of pharmaceutical analysis & Quality Assurance GITAM Institute of PharmacyGITAM University department of pharmaceutical analysis & Quality Assurance Roland Institute of Pharmaceutical Sciences

A stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Letrozole in tablet dosage forms. Reversed-phase chromatography was performed on Shimadzu Model LC-Class-Vp with Lichrocart/Lichrosphere 100 C-18 (250 mm 4.6 mm, 5 mm particle size) column with methanol: tetra butyl ammonium hydrogen sulfate (80:20V/V) as mobile phase at a flow rate of 1 mL/min with UV detection at 240 nm. Linearity was observed in the concentration range of 0.5-150 mg/mL (R 2 0.9998) with regression equation y 102582xt43185. The limit of quantitation (LOQ) and limit of detection (LOD) were found to be 0.043 and 0.012 mg/mL respectively. The forced degradation studies were performed by using HCl, NaOH, H 2 O 2 , thermal and UV radiation. Letrozole is more sensitive towards alkaline conditions and very much resistant towards acidic, oxidative and photolytic degradations. The method was validated as per ICH guidelines. The RSD for intra-day (0.78-0.97) and inter-day (0.86-0.96) precision were found to be lesser than 1%. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations and the method is simple, specific, precise and accurate for the determination of Letrozole in pharmaceutical formulations.

关键词： Letrozole Liquid chromatography Stability-indicating

Solriamfetol impurities:Synthesis,characterization,and analytical method(UPLC-UV)validation

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Journal of pharmaceutical analysis 2023年第4期13卷 403-411页

作者： Nafisah Al-Rifai Anas Alshishani Fouad Darras Ola Taha Shereen Abu-Jalloud Lena Shaghlil Yousef Al-Ebini pharmaceutical and Chemical Engineering department School of Medical SciencesGerman Jordanian UniversityAmmanJordan Faculty of pharmacy Zarqa UniversityZarqaJordan Research and Development department Resonance Research LabAmmanJordan department of Pharmaceutics College of PharmacyKing Khalid UniversityAbhaSaudi Arabia

Given that impurities may affect the quality and safety of drug products,impurity identification and profiling is an integral part of drug quality control and is particularly important for newly developed medications such as solriamfetol,which is used to treat excessive daytime *** the highperformance liquid chromatography analysis of commercial solriamfetol has revealed the presence of several impurities,their synthesis,structure elucidation,and chromatographic determination have not been reported *** bridge this gap,we herein identified,synthesized,and isolated eight processrelated solriamfetol impurities,characterized them using spectroscopic and chromatographic techniques,and proposed plausible mechanisms of their ***,we developed and validated a prompt impurity analysis method based on ultrahigh-performance liquid chromatography with UV detection,revealing that its selectivity,linearity,accuracy,precision,and quantitation limit meet the acceptance criteria of method validation stipulated by the International Council for Harmonization of Technical Requirements for pharmaceuticals for Human ***,the developed method was concluded to be suitable for the routine analysis of solriamfetol substances.

关键词： Solriamfetol Impurity analysis Impurity synthesis UPLC Method validation