{"title":"Identification Of Methamphetamine and Amphetamine in Drug Abuse Urine Sample using Multi-drug Rapid Test and Gas Chromatography-Mass Spectrometry (GC-MS) at the Centre of Drug Testing Laboratory, National Narcotics Board Republic of Indonesia","authors":"Kurnia Sandy, T. Rahmania, Eri Arfiyani","doi":"10.2174/1573412919666230803102859","DOIUrl":"https://doi.org/10.2174/1573412919666230803102859","url":null,"abstract":"\u0000\u0000Drug abuse is a real threat that threatens the Indonesian nation in the form of non-military threats. The second most abused illicit substance in the world is methamphetamine (MA). Most of the methamphetamine users in the world live in East and Southeast Asia. Methamphetamine is a powerful stimulant of the central nervous system (CNS) that can make someone feel an increase in sympathomimetic.\u0000\u0000\u0000\u0000First, the preliminary test was conducted using a BioCare multi-drug rapid test and a specific methamphetamine rapid test that works based on the Lateral Flow Assay (LFA) principle. Second, the sample preparation used Liquid-Liquid Extraction (LLE). Third, GC-MS confirmed the test using GC-MS Shimadzu-QP2020NX-GC-2030 (HP-5MS column, Length 30 m, diameter 0.25 m, film 0.25).\u0000\u0000\u0000\u0000The Preliminary test shows that the urine is positive and contains methamphetamine and amphetamine. Based on the sample chromatogram, There are 2 peaks, which are methamphetamine and amphetamine compounds it can be seen by the retention time is 5.560 minutes (methamphetamine) a similarity index of 98% to methamphetamine compounds, and 4.885 minutes (amphetamine) with a similarity index of 96% to amphetamine compounds.\u0000\u0000\u0000\u0000The urine samples with code 210DGB from methamphetamine users were detected due to the presence of methamphetamine and amphetamine, which is the metabolite of methamphetamine.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":" ","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48867919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yanjun Hao, Jianzhong Qi, Hongli Wang, Lu Dai, Lei Shi, Haigang Chen
{"title":"Researches on detection of related substances in drugs","authors":"Yanjun Hao, Jianzhong Qi, Hongli Wang, Lu Dai, Lei Shi, Haigang Chen","doi":"10.2174/1573412919666230725143826","DOIUrl":"https://doi.org/10.2174/1573412919666230725143826","url":null,"abstract":"\u0000\u0000The production of drugs is very complicated. In the process of preparation and transportation, mixing a small amount of reaction raw materials, intermediates, and storage degradation products is inevitable, which affect the quality of drugs. The quality of drugs not only affects\u0000the efficacy, but also produces unpredictable side effects and toxicity, which is directly related to\u0000people's life and health. The detection of drug quality has always been the focus of attention. Related substance research is one of the key projects in drug quality research, and its content is a direct indicator of drug purity. Therefore, it is very important to establish the content standard of\u0000drug related substances and develop the detection method of related substances. The related substances of drugs are rich in variety, with different physical and chemical properties, and the components of related substances, such as degradation products need further analysis, which makes it\u0000difficult to effectively apply the detection methods. After years of research, the detection methods\u0000of related substances are constantly updated and improved. At present, the detection methods of\u0000related substances involve physical, chemical, and other fields, including chemical methods,\u0000chromatography, and spectroscopy. In this paper, the research progress of detection methods for\u0000related substances in drugs in recent years was reviewed, and the types, features, and application\u0000scope of detection methods were summarized, providing reference for quality control of chemical\u0000synthetic drugs and traditional Chinese medicines. Therefore, this work provides new ideas for the\u0000development of more accurate and efficient detection methods.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":" ","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43251922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
B. Devi, K. Madhavi, Swathi Naraparaju, Rajeshwari Deverakonda
{"title":"Use of Chemical Reagents in Non-Fluorescent Pharmaceutical Labels: A Comprehensive Review","authors":"B. Devi, K. Madhavi, Swathi Naraparaju, Rajeshwari Deverakonda","doi":"10.2174/1573412919666230609120450","DOIUrl":"https://doi.org/10.2174/1573412919666230609120450","url":null,"abstract":"\u0000\u0000Spectrofluorimetry is an analytical technique with high sensitivity, specificity, and simplicity, and is very economical. Drugs that lack native fluorescence are derivatized with reagents so that highly fluorescent compounds are formed that can be readily detected by spectrofluorimetry. There are different reagents such as 4-chloro-7-nitrobenz-2-oxa-1,3-diazole (NBD-Cl), N- methylnicotinamide chloride (NMNCl), 9-flurenylmethylchloroformate (FMOC-Cl), dansylchloride (DNS-Cl), 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH), 1,2-naphthoquinone-4-sulfonate (NQS), 1,4- benzoquinone, 4-fluro-7-nitrobenzofurazan (NBD-F), ninhydrin, benzoin, N- bromo succinimide (NBS), acetylacetone & HCHO, ortho-phthalaldehyde (OPA), and 2-cyanoacetamide used in spectrofluorimetric determination of the drugs that lack native fluorescence. The present review highlights these reagents with principle, reaction conditions, and their applications.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":" ","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42454396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Determination of Two Potential Genotoxic Impurities in Crisaborole API by UPLC-MS/MS","authors":"Q. Zou, Mengmeng Zhang","doi":"10.2174/1573412919666230609152143","DOIUrl":"https://doi.org/10.2174/1573412919666230609152143","url":null,"abstract":"\u0000\u0000Atopic dermatitis (AD) is an allergic skin disease that can be inherited. Crisaborole is a specific drug developed to deal with this disease. The compounds of 4-(4-Bromo-3-formyl-phenoxy)-benzonitrile and 4-(4-(4-bromo-3-formylphenoxy)-3- formylphenoxy)benzonitrile are the representative impurities in the synthesis of Crisaborole active pharmaceutical in gradient (API). Owing to the genotoxic impurities that could lead to cancer and gene mutations, it is necessary to develop a simple, efficient, sensitive, and accurate method to detect these impurities. In this study, the 4-(4-Bromo-3-formyl-phenoxy)-benzonitrile and 4-(4-(4-bromo-3-formylphenoxy)-3-formylphenoxy)benzo- nitrile present in Crisaborole API were detected using UPLC-MS/MS.\u0000\u0000\u0000\u0000The separation was made on a ZORBAX Eclipse XDB-Pheny column (4.6 mm ×75mm, 3.5 μm) with the mobile phase of acetonitrile solution containing 0.1% trifluoroacetic acid (A) and water containing 0.1% formic acid (B) in gradient elution mode. Quantification was performed using positive ion electrospray ionization (ESI), and the contents of two compounds were determined using the multiple reaction monitoring (MRM) modes.\u0000\u0000\u0000\u0000The quantitative analytical method was fully validated with respect to linearity (r>0.9998), sensitivity, precision, accuracy (the average recovery of two impurities was 84.1% to 90.7%), and robustness.\u0000\u0000\u0000\u0000Three batches of samples were detected by UPLC-MS/MS, indicating that the proposed approach was applicable for the quality evaluation of Crisaborole.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42031469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development of a Suitable HPLC Method for the Analysis of Impurities in Clorprenaline and Bromhexine Capsules and Identification of Unknown Impurities by 2D LC-Q-TOF MS","authors":"Yunfeng Shi, Liqin Lin, Qi Yao, Xiaojuan Ren, Fengmei Zhang","doi":"10.2174/1573412919666230601140557","DOIUrl":"https://doi.org/10.2174/1573412919666230601140557","url":null,"abstract":"\u0000\u0000In order to determine the impurities in compound clorprenaline and bromhexine capsules, a new stability-indicating HPLC method was established. A Boston Green ODS column was used, and the UV detection was 225nm. The influences of the gradient elution program, the composition ratio of the mobile phase and the velocity of flow on the separation of impurities in clorprenaline and bromhexine capsules were investigated. The developed methods were validated by assessing linearity, range, accuracy, the limit of detection (LOD), the limit of quantitation (LOQ), and robustness. The experimental results showed that the three components had good linearity, and the correlation coefficients were greater than 0.999. The recoveries of clorprenaline hydrochloride, decloxizine hydrochloride, and bromhexine hydrochloride were in the range of 95.0 to 102.3%. The LOD and LOQ values of clorprenaline hydrochloride, decloxizine hydrochloride, and bromhexine hydrochloride were between 0.20 and 0.82 μg•mL-1.\u0000Moreover, two unknown impurities were identified by two-dimensional liquid chromatography-tandem with quadrupole/time-of-flight mass spectrometry in electrospray ionization mode. Impurity 1 was derived from chlorohydroxazine hydrochloride, which has not been reported in the literature. Impurity 2 was derived from bromhexine hydrochloride, and its structure was the same as that of impurity E in EP 10.0 quality standard for bromhexine hydrochloride. The established method was highly specific, sensitive, accurate, and suitable for routine quality control of clorprenaline and bromhexine capsules. The structures of unknown impurities were characterized by the MS/MS data.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":" ","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42237321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Determination of Antithyroid drug Propylthiouracil with Ru (III) in Pharmaceutical formulations and its characterization","authors":"Afraim Koty, Mukul Sharma","doi":"10.2174/1573412919666230524140341","DOIUrl":"https://doi.org/10.2174/1573412919666230524140341","url":null,"abstract":"\u0000\u0000Sulfur serves as a versatile element and an essential constituent of pharmaceutical industries, natural compounds, proteins, and biological systems. One of the fundamental constituents of sulfur is thiouracil, which forms several derivatives, including 6-methylthiouracil, 6-methyl-2-thiouracil, and 6-propylthiouracil. These derivatives act as effective chelating agents and can form complexes with metal ions.\u0000\u0000\u0000\u0000Sulfur serves as a versatile element and an essential constituent of pharmaceutical industries, natural compounds, proteins, and biological systems. One of the fundamental constituents of sulfur is thiouracil, which forms several derivatives, including 6-methylthiouracil, 6-methyl-2-thiouracil, and 6-propylthiouracil. These derivatives act as effective chelating agents and can form complexes with metal ions.\u0000Compared with other metals, ruthenium possesses unique chemical properties that make it an ideal therapeutic agent. Therefore, this study reports on the propylthiouracil: Ru(III) complex, considering these essential facts.\u0000\u0000\u0000\u0000An equimolar amount of ruthenium trichloride 3.34 x 10-5 M was added to various aliquots ranging from 0.4 mL to 8.8 mL of 3.26 x 10−5 M propylthiouracil. The volume was adjusted to 10 mL with double distilled water. After letting the solution stand for 10 min, we recorded the absorbance of different sets at λmax 376 nm. The Beer-Lambert's law graph demonstrated linearity in the concentration range of 3.18 x101 gmL-1 to 7.96 x102 gmL-1, with a linear regression equation of Y = 0.0354 + 0.1109 X. We determined the effective molar absorptivity (ε) to be 6.609 x 102 Lmole-1 cm-1, and the relative standard deviation (RSD %) was ± 0.34%.\u0000\u0000\u0000\u0000At room temperature, a yellow-colored complex of propylthiouracil: Ru(III) was formed within 10 min, with a λmax of 376 nm and constant color intensity for 24 h. We confirmed and characterized the formed complex using FTIR, ESR, 1HNMR, thermal analysis, magnetic susceptibility, and powder X-ray.\u0000\u0000\u0000\u0000This approach is notable for its precision, accuracy, rapidity, cost-effectiveness, and applicability in tablet form. The novel propylthiouracil: Ru(III) complex offers several advantages, including stability, low absorbance, and no interference with water-soluble ions, eliminating the need for an organic solvent to extract the reaction product. Therefore, this approach could be recommended for quality control in the pharmaceutical industry.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":" ","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49559722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Chopra, Prashant K. Chaturvedi, Kalyani H. Joshi, S. Tauro, Pintu B. Prajapati
{"title":"Pitfalls and Opportunities in the Execution of Quality by Design in Analytical\u0000Sciences","authors":"S. Chopra, Prashant K. Chaturvedi, Kalyani H. Joshi, S. Tauro, Pintu B. Prajapati","doi":"10.2174/1573412919666230517141015","DOIUrl":"https://doi.org/10.2174/1573412919666230517141015","url":null,"abstract":"\u0000\u0000Quality by Design (QbD) is a systematic approach integrated with quality risk management.\u0000It uses different design approaches followed by statistical analysis to yield a quality\u0000product. Now, the pharmaceutical industries are intrested in the application of QbD principles to\u0000analytical methods and term it as Analytical QbD (AQbD), which does not essentially mean less\u0000analytical testing; to a particular extent, it means the right analysis at the right time, supported by\u0000science and risk evaluation which ensures that the analytical method can be improved throughout\u0000its life cycle. However, for that, the analyst must have sound knowledge of Analytical Target Profile\u0000(ATP), method performance characteristics, risk assessment, choice of Design of Experiment\u0000(DoE), optimization of Method Operable Design Region (MODR). Some papers have cited the\u0000importance, regulatory flexibility, theoretical aspects, and statistical analysis of AQbD, but only a\u0000few discuss the core issue of gradual implementation of QbD in analytical sciences. For seamless\u0000transition, researchers need clarification on AQbD terminologies, acceptable methods, criteria to\u0000embrace critical quality attributes (CQAs), and standards to judge the adequacy of controls. This\u0000paper summarizes the challenges and solutions for the implementation of AQbD.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":" ","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44426209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}