Drug Analytical Research最新文献_第2页

Lipid core nanocapsules-loaded tacrolimus: Development and evaluation of quality parameters 脂质核纳米胶囊负载他克莫司:质量参数的开发和评价

Drug Analytical Research Pub Date : 2022-07-28 DOI: 10.22456/2527-2616.125229

Graziela Scheuer Gomes, L. Frank, Adriana Raffin Pohlmann, Silvia Stanisçuaki Guterres

{"title":"Lipid core nanocapsules-loaded tacrolimus: Development and evaluation of quality parameters","authors":"Graziela Scheuer Gomes, L. Frank, Adriana Raffin Pohlmann, Silvia Stanisçuaki Guterres","doi":"10.22456/2527-2616.125229","DOIUrl":"https://doi.org/10.22456/2527-2616.125229","url":null,"abstract":"This study aimed to revalidate an HPLC-based analytical methodology to determine tacrolimus within lipid-core nanocapsules and to evaluate the quality of such nanosystems. Chromatographic separation was achieved by employing a C18 column as a stationary phase and a ternary mixture of acetonitrile: water: phosphoric acid (700:299:1 v/v) as the mobile phase. The revalidated method proved to be linear in the range of 1-60 µg.mL−1 for tacrolimus (r2 >0.999). Detection and quantification limits were 45.38 ng.mL-1 and 137.51 ng.mL-1, respectively, which assures the methodology sensitivity. The method was also precise (RSD = 1.78% between samples). Besides, the methodology demonstrated accuracy and robustness. The lipid-core nanocapsules-loaded tacrolimus showed exclusively nanosized particles (±190 nm and polydispersity index of ≤v0.2), negative zeta potential (-13.67±1.16), and slightly acidic pH (5.58 ± 0.06), with a content of 98.90±2.32% and encapsulation rate of 99.23±0.32%. Tacrolimus-loaded in lipid-core nanocapsules-loaded tacrolimus showed stability for at least 30 days at room temperature and a sustained release profile compared to the drug in solution.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83644043","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}

引用次数: 1

Analytical methods of phytochemicals from the Cuphea genus - A review Cuphea属植物化学成分分析方法综述

Drug Analytical Research Pub Date : 2021-12-15 DOI: 10.22456/2527-2616.120618

M. C. Santos, A. Henriques, A. Mendez

引用次数: 2

Evaluation of artificial drug incorporation into hair for the production of quality control samples 头发中掺入人工药物质量控制样品的评价

Drug Analytical Research Pub Date : 2021-12-15 DOI: 10.22456/2527-2616.118887

F. Roveri, A. F. Pego, Sarah Eller, T. Oliveira, M. Yonamine

{"title":"Evaluation of artificial drug incorporation into hair for the production of quality control samples","authors":"F. Roveri, A. F. Pego, Sarah Eller, T. Oliveira, M. Yonamine","doi":"10.22456/2527-2616.118887","DOIUrl":"https://doi.org/10.22456/2527-2616.118887","url":null,"abstract":"Hair analysis is thoroughly used in forensic toxicology although there are still some points of concern such as lack of reference material, whether for internal quality controls (IQC) or even for analytical validation process verification. Nonetheless spiked samples are still widely used, mainly for method development, it is not possible to evaluate its actual reproducibility and accuracy. As an alternative, IQC could be produced artificially by the laboratories themselves. The aim of this work was the evaluation of the phenomenon of artificial incorporation of drugs into hair to produce internal quality controls. These controls have been prepared according to the recommendations from the National Institute of Standards and Technology. For the amphetamine group, amphetamine and MDMA, showed different incorporation rates, of 0.17 up to 0.5% for amphetamine and 0.10 up to 0.4% for MDMA. As for cocaine, the incorporation rate was progressive over the course of days, ranging from 0.15 to 0.75%. The highest incorporation was found for diazepam, from 0.57%. to 3.75%. Lower rates were obtained for morphine, ranging from 0.08 to 0.25%, given that the incorporation rate of 0.25% has been reached on the ninth day. Some factors such as incubation time, agitation process and sample washing probably influenced the way analytes incorporate into the matrix including the effects of homogenization of the samples. Overall, knowing the incorporation profile of each analyte it is possible to produce IQC, with different concentrations. Thus, laboratories will have the fortified samples as a better tool for evaluating their own methodology.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87092143","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}

引用次数: 0

Development and validation of a dissolution test for empagliflozin in film-coated tablets 恩格列净薄膜包衣片溶出度测定方法的建立与验证

Drug Analytical Research Pub Date : 2021-12-15 DOI: 10.22456/2527-2616.112077

J. W. Manoel, Gabriele Bordignon Primieri, N. Volpato, M. Steppe

引用次数: 0

Rapid stability-indicating UHPLC method for determination of lamivudine and tenofovir disoproxil fumarate in fixed-dose combination tablets 快速稳定指示UHPLC法测定拉米夫定和富马酸替诺福韦二氧吡酯固定剂量联合片中含量

Drug Analytical Research Pub Date : 2021-12-15 DOI: 10.22456/2527-2616.117905

Danielle Evangelista Rabelo De Souza, Nicoly Kaliny Magela Gomes, G. A. Pianetti, B. G. Pereira, C. Fernandes

{"title":"Rapid stability-indicating UHPLC method for determination of lamivudine and tenofovir disoproxil fumarate in fixed-dose combination tablets","authors":"Danielle Evangelista Rabelo De Souza, Nicoly Kaliny Magela Gomes, G. A. Pianetti, B. G. Pereira, C. Fernandes","doi":"10.22456/2527-2616.117905","DOIUrl":"https://doi.org/10.22456/2527-2616.117905","url":null,"abstract":"Lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) are antiretroviral drugs widely used for AIDS treatment. Since safety, efficacy and quality are essential for drug products, stability studies must be performed. Therefore, degradation studies must be carried out to evaluate the degradation products formed. The active pharmaceutical ingredients 3TC and TDF, as well as the tablets containing the combination of these drugs were subjected to a comprehensive forced degradation. 3TC, TDF and the degradation products were analyzed by a stability-indicating ultra-high performance liquid chromatography (UHPLC) method developed and validated. A C8 (100 x 2.0 mm, 2.2 μm) column and a mobile phase composed of 0.1 M ammonium acetate buffer pH 4.0, acetonitrile and methanol in gradient elution, at 0.5 mL/min, were used. The injection volume was 4 μL and detection was at 260 nm. The method was selective, precise, accurate and linear in the range 0.1-0.6 mg mL-1 for the two drugs. 3TC was degraded in acidic, alkaline and oxidative environment and in the presence of metal ions. Two degradation products were observed. TDF was degraded in the same conditions than those 3TC was labile. In addition, TDF was degraded in neutral condition. Again, two degradation products were formed. Chemical structures were proposed for the degradation products using UHPLC-QTOF/MS. The stability-indicating method developed showed to be useful in stability studies and in the quality control of fixed-dose combination tablets containing 3TC and TDF.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88419051","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}

引用次数: 0

LC method for quantitative determination of Ciprofloxacin in ophthalmic ointment 液相色谱法测定眼膏中环丙沙星的含量

Drug Analytical Research Pub Date : 2021-12-15 DOI: 10.22456/2527-2616.118365

Lionel Salem Aza-Gnandji, L. Bueno, T. P. Oppe, E. Schapoval

引用次数: 1

Lead evaluation in children's lipsticks through atomic absorption spectrometry 原子吸收光谱法测定儿童口红中的铅

Drug Analytical Research Pub Date : 2021-12-15 DOI: 10.22456/2527-2616.117544

Silvia Cristina Fagundes, L. G. Rossato-Grando, Camila Favretto Souza, Oberdan Fiorentin, C. M. Mistura, C. Bertol

引用次数: 0

Ceftaroline fosamil: development a rapid HPLC method indicating stability and bioassay for determination in pharmaceutical formulation, stability and cytotoxicity studies 头孢他林化石油:建立一种快速高效液相色谱法，用于药物配方、稳定性和细胞毒性研究的稳定性和生物测定

Drug Analytical Research Pub Date : 2021-12-15 DOI: 10.22456/2527-2616.120343

Idamir José Mascarello Junior, R. Sponchiado, Leticia Malgarin Cordenonsi, Tércio Oppe Oppe, E. E. S. Shapoval

{"title":"Ceftaroline fosamil: development a rapid HPLC method indicating stability and bioassay for determination in pharmaceutical formulation, stability and cytotoxicity studies","authors":"Idamir José Mascarello Junior, R. Sponchiado, Leticia Malgarin Cordenonsi, Tércio Oppe Oppe, E. E. S. Shapoval","doi":"10.22456/2527-2616.120343","DOIUrl":"https://doi.org/10.22456/2527-2616.120343","url":null,"abstract":"The present study reports the development and validation of a microbiological assay. To assess this methodology, the method was developed and validated for the quantification of CEF by high performance liquid chromatography (HPLC). The validation of the microbial assay by diffusion method in 3x3 cylinder agar presented showed satisfactory results as to specificity, linearity in the range of 2.0 - 8.0 μg.mL-1, precision (109.42 %), accuracy (102.3 %), and robustness. The development and validation of the method by HPLC were evaluated according to specificity, linearity, precision, accuracy and robustness. A high performance liquid chromatography from Shimadzu with Agilent® C18 column, mobile phase (water with triethylamine 1.0 % pH 5.0: acetonitrile 87:13 v/v was used in the chromatographic method. The validated microbiological and chromatographic methods were compared statistically and there was no significant difference between them when compared by Student's t-test. In the preliminary stability study, it was found stable in acid hydrolysis (0.1M) and UVA light in the period evaluated, and unstable against thermal degradation (40 and 60 °C), oxidative with hydrogen peroxide, basic in NaOH (0.1 M and 0.01M) and UVC light. Samples exposed to UVC light and thermal degradation at 60°C showed degradation kinetics following zero order and second order, respectively. The cytotoxicity assay showed no difference between the normal condition and the sample submitted to forced degradation, suggesting that the possible degradation products formed did not change the result. The methods developed did not present a significant difference, therefore, they are interchangeable, and so can be used for routine quality control analysis.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76928460","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}

引用次数: 1

Use of Box–Behnken design for optimization of compounded medication: acyclovir capsules report 用Box-Behnken设计优化复方药物:阿昔洛韦胶囊报告

Drug Analytical Research Pub Date : 2021-06-30 DOI: 10.22456/2527-2616.113283

Suelen Da Silva Reis, Valdemir Da Silva Quintanilha Junior, Gabriella Da Silva Boto, Thalita Martins Da Silva, Elizabeth Valverde Macedo, C. A. F. Peregrino, S. Mourão, Emeli Moura De Araújo

{"title":"Use of Box–Behnken design for optimization of compounded medication: acyclovir capsules report","authors":"Suelen Da Silva Reis, Valdemir Da Silva Quintanilha Junior, Gabriella Da Silva Boto, Thalita Martins Da Silva, Elizabeth Valverde Macedo, C. A. F. Peregrino, S. Mourão, Emeli Moura De Araújo","doi":"10.22456/2527-2616.113283","DOIUrl":"https://doi.org/10.22456/2527-2616.113283","url":null,"abstract":"Campus compounding pharmacies play an important role in public health. Herpes simplex is one of the most common viral diseases in humans, which generates a great demand for acyclovir capsules in compounding pharmacy. It is well known that the formulation's components influence the effectiveness of the drug. The objective of this study is to show the applicability of Box-Behnken design in optimization of a compounded formulation and to evaluate the effect of excipients on dissolution and drug content in acyclovir 200 mg capsules produced at UFF´s University Pharmacy (FAU). The formulations were prepared and evaluated for average weight test, uniformity of dosage units and in vitro dissolution, while meeting pharmacopoeial specifications. A statistical analysis showed that sodium starch glycolate, Aerosil®, influences drug content and dissolution results. Magnesium stearate shows no influence on the dissolution at different concentrations but influences the assay results. A numerical optimization was applied to adjust the formulation variables based on the foresaid responses, accomplishing the best formulation that will be prepared and dispensed at FAU upon medical prescription.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83226477","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}

引用次数: 0

A novel sensitive colorimetric determination of catecholamine drug in dosage form via oxidative coupling reaction with MBTH and potassium ferricyanide 用MBTH和铁氰化钾氧化偶联法测定剂量型儿茶酚胺

Drug Analytical Research Pub Date : 2021-06-30 DOI: 10.22456/2527-2616.113058

S. Ashour

{"title":"A novel sensitive colorimetric determination of catecholamine drug in dosage form via oxidative coupling reaction with MBTH and potassium ferricyanide","authors":"S. Ashour","doi":"10.22456/2527-2616.113058","DOIUrl":"https://doi.org/10.22456/2527-2616.113058","url":null,"abstract":"A new and direct colorimetric method has been established for the determination of catecholamine (methyldopa, MD) in both pure form and in pharmaceutical formulations. The method is based on the oxidative coupling reaction of MD with 3-methyl-2-benzothiazolinone hydrazone hydrochloride monohydrate (MBTH) and potassium ferricyanide at pH 10.4 in aqueous medium to form an orange product that has a maximum absorption at 460 nm. Beer's law plot showed good correlation in the concentration range of 1.0−56.0 µg mL-1, with detection limit of 0.31 µg mL-1. Molar absorptivity for the above method was found to be 6.56×103 L mol-1 cm-1. All the measurements were carried out at 25 ± 1.0 °C, the formation constant (logKf) value of colored species is 9.48 and the standard free energy (DG‡) is − 54.09 KJ mol-1. This method was applied successfully to determination of MD in tablets and the results were compared with the USP method. Common excipients used as additives in tablets do not interfere in the proposed method. The method is accurate, precise and highly reproducible, while being simple, cheap and less time consuming and hence can be suitably applied for routine analysis of MD in bulk and dosage forms.","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79605040","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}

引用次数: 2