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Development and Validation of a HPLC Method for the Estimation of Tizanidine and Ibuprofen in Bulk and Dosage forms 替扎尼定和布洛芬原料药和剂型的HPLC测定方法的建立与验证
Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00040
Md. Abdul Sattar, M. S. Sree Lakshmi, D. S. Jyothi, M. Sudha, M. K. Siva Krishna
A new method was established for estimation of Tizanidine and Ibuprofen by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tizanidine and Ibuprofen by using Intersil ODS C18 column (250×4.6mm) 5.0µm, flow rate was 1.0ml/min, mobile phase ratio was (40:60 v/v) Potassium di hydrogen Phosphate Buffer: Acetonitrile pH 3.2 (pH was adjusted with Ortho-phosphoric acid), detection wavelength was 269nm. The instrument used was Shimadzu HPLC, UV detector 2450, Spinchrom -software version-2. The method shows linearity between the concentration range of 0.6-1.4µg/ml for Tizanidine and 120-280 for Ibuprofen. The % recovery of Tizanidine and Ibuprofen were found to be in the range of 98.0% - 102.0%. As there was no interference due to mobile phase, the method was found to be specific. The method was robust as observed from insignificant variation in the results of analysis by changes in Flow rate and wavelength variation separately and analysis being performed by different analysts.
建立了反相高效液相色谱法测定替扎尼定和布洛芬含量的新方法。采用Intersil ODS C18色谱柱(250×4.6mm) 5.0µm,流速1.0ml/min,流动相比(40:60 v/v)磷酸氢钾缓冲液:乙腈pH 3.2(以正磷酸调节pH),检测波长269nm,建立了替扎尼定和布洛芬的分离色谱条件。采用岛津高效液相色谱法,紫外检测器2450,Spinchrom -软件版本2。替扎尼定的浓度范围为0.6 ~ 1.4µg/ml,布洛芬的浓度范围为120 ~ 280µg/ml。替扎尼定和布洛芬的回收率在98.0% ~ 102.0%之间。由于不存在流动相的干扰,该方法具有特异性。通过分别改变流量和波长变化以及由不同的分析人员进行分析,可以看出该方法具有较强的鲁棒性。
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引用次数: 0
Monoclonal Antibodies as a Site Specific Particulate Drug Delivery System: A Review 单克隆抗体作为位点特异性颗粒给药系统的研究进展
Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00047
G. Shinde, K. Prasad, R. S. Jadhav, D. Vikhe
Monoclonal antibodies are antibodies that are identical because they were produced by one type of immune cell, all Human monoclonal antibody immunotherapy in clinical medicine has been an exciting prospect for some time, and increasing numbers of such antibodies have gradually become available. Targets and basic characterization of novel classes of bioactive agents, to the development of ‘designer’ or ‘smart’ materials which provide required excipient or carrier properties to achieve modulated and targeted drug delivery. Drug particle engineering, or crystal engineering, provides an additional dimension to drug delivery and targeting. Traditional methods of particle formation, crystallization. Antibodies can be heterogeneous with respect to size, charge, antigen specificity, and affinity. These factors may be significant when antibodies are used as a drug delivery system. Drug targeting and delivery using antibodies has been most useful in the field of chemotherapy because this is an area of research in which there is the greatest need for target-site specificity. Antibodies have been found to have many applications in the management of human carcinomas, including colorectal, gastric, ovarian, endometrial, breast, lung.
单克隆抗体是由一种免疫细胞产生的相同的抗体,临床医学中所有的人类单克隆抗体免疫治疗已经有了一段令人兴奋的前景,并且越来越多的这种抗体已经逐渐可用。新型生物活性制剂的目标和基本特征,到“设计”或“智能”材料的开发,这些材料提供所需的赋形剂或载体特性,以实现调制和靶向药物递送。药物颗粒工程或晶体工程为药物传递和靶向提供了额外的维度。传统的颗粒形成、结晶方法。抗体在大小、电荷、抗原特异性和亲和力方面可以是异质的。当抗体被用作药物输送系统时,这些因素可能是重要的。使用抗体的药物靶向和递送在化疗领域是最有用的,因为这是一个最需要靶向位点特异性的研究领域。抗体已被发现在人类癌症的治疗中有许多应用,包括结直肠癌、胃癌、卵巢癌、子宫内膜癌、乳腺癌、肺癌。
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引用次数: 0
Development of UV- Spectrophotometric Method for Simultaneous Estimation of Metformin and Piperine in Combined Tablet Dosage Form 紫外分光光度法同时测定复方片剂中二甲双胍和胡椒碱含量的建立
Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00036
S. Venkatesh, V. Laxmi, Rajeswari Chiluka, Y. Padmavathi
Piperine is an alkaloid obtained from Piper nigrum Linn., is known to modify the biotransformation of the drugs by inhibiting Cytochrome P450 forms. Piperine inhibits the bio-transformation and metabolism of metformin leading to higher levels of drug in systemic circulation, thus increases the bioavailabilty when co-administered with metformin. In the present study a simple, accurate, precise, economical procedures, entailing neither irksome sample treatment nor tedious extraction process a combined tablet dosage form of metformin and piperine have been developed for the simultaneous estimation of piperine and metformin using UV- Spectrophotometry method. The developed method was based on employing simultaneous equation method for analysis of both the drugs. Metformin and piperine have shown absorbance maxima at 237nm and 342nm respectively, in methanol and the linearity was obeyed over the concentration range of 2-10μg/ml and 2-10 μg/ml respectively for metformin and piperine. The validation parameters like precision, accuracy, limit of quantitation (LOQ), limit of detection (LOD), were determined according to ICH guidelines. All the results were found to be within the limits.
胡椒碱是一种从胡椒中提取的生物碱。已知通过抑制细胞色素P450形式来修饰药物的生物转化。胡椒碱抑制二甲双胍的生物转化和代谢,导致体循环中药物水平升高,从而增加与二甲双胍合用时的生物利用度。本研究开发了一种简单、准确、精确、经济的方法,既不需要繁琐的样品处理,也不需要繁琐的提取过程,即二甲双胍和胡椒碱的联合片剂剂型,用于紫外分光光度法同时测定胡椒碱和二甲双胍。该方法采用联立方程法对两种药物进行分析。二甲双胍和胡椒碱在甲醇中的吸光度分别在237nm和342nm处达到最大值,在2-10μg/ml和2-10μg/ml浓度范围内呈线性关系。精密度、准确度、定量限(LOQ)、检出限(LOD)等验证参数根据ICH指南确定。所有的结果都在限定范围内。
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引用次数: 1
Development of Antimalarial Pharmacotherapy and its importance in Malaria Treatment/Public Health Program 抗疟药物治疗的发展及其在疟疾治疗/公共卫生规划中的重要性
Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00038
Anil K Agarwal, A. Yadav, C. P, Paromita Kuity, Jaya Mishra
Aim/Objective: The primary objective of this review is to describe the Evolution of current allopathic Anti-malarial Pharmacotherapy and understanding significance of Antimalarial drugs in Malaria Program/Public Health Program in India. Subject/Method: Review of Research Literature and Context-Content-Outcome Analysis of Antimalarial Drug Policy. Findings: Antimalarial drug list expanded extensively and the drug dose intensity is proportional to disease transmission in region/area; both the factors medicalizing the community significantly. The conceptual understanding of malaria remains within biomedicine domain evidenced by the fact that much of importance (over-reliance) given to least effective individual level technical interventions like drugs that too; without considering immunity and nutritional status of both individual and community. Indian Planners seems confused to differentiate (or ignoring) between Malaria’s behavior at Individual level and community level. Thus, the Malaria planning lacks ethical consideration for resource allocation in Public Health Planning evidenced by the fact that large resources allocated to least effective intervention that serves the profit making purpose of private sector pharma industry. Sufferings of the most impoverished household of community remain unaddressed in Health planning. Policy for Antimalarial Pharmacotherapy is unable to serve its primary purpose of relieving suffering of community, prevention of mortalities, reducing morbidities, slowing down the resistance, and reducing drug load in community. Conclusion: The investment in medications to tackle malaria as Public Health problem looks costly investments as it consumes heavy resources and its benefits/success claim is questionable. There is mismatch in planning and field reality as intervention in the form of drugs does not match the requirement as per epidemiological complexity. Health Planning is comprehensive exercise for any country. Ignoring voices from field/frontline workers prove detrimental for health planning. Every organization or individual involved in health planning would be having different opinions as per their interest but the final decision regarding resource allocation should consider the field reality following good public health ethics.
目的/目的:本综述的主要目的是描述当前对抗疗法抗疟疾药物治疗的发展,并了解抗疟疾药物在印度疟疾计划/公共卫生计划中的意义。主题/方法:研究文献综述及抗疟药物政策的背景-内容-结果分析。结果:抗疟药物目录广泛扩展,药物剂量强度与地区/地区疾病传播成正比;这两个因素都使社区医疗化。对疟疾的概念性理解仍然局限于生物医学领域,事实证明,对最不有效的个人层面技术干预措施(如药物)的重视(过度依赖)也很重要;不考虑个人和社区的免疫和营养状况。印度的规划者似乎对区分(或忽视)疟疾在个人层面和社区层面的行为感到困惑。因此,疟疾规划在公共卫生规划中缺乏对资源分配的伦理考虑,事实证明,大量资源分配给了服务于私营部门制药行业盈利目的的最不有效的干预措施。社区最贫困家庭的苦难在卫生规划中仍未得到解决。抗疟药物治疗政策无法达到减轻社区痛苦、预防死亡、降低发病率、减缓耐药性和减少社区药物负荷的主要目的。结论:将疟疾作为公共卫生问题的药物的投资看起来是昂贵的投资,因为它消耗大量资源,其效益/成功的说法值得怀疑。由于以药物形式进行的干预不符合流行病学复杂性的要求,规划与现场实际情况不匹配。健康规划对任何国家来说都是一项全面的锻炼。忽视现场/一线工作人员的声音不利于卫生规划。参与卫生规划的每个组织或个人都会根据自己的利益有不同的意见,但有关资源分配的最终决定应遵循良好的公共卫生道德,考虑实地的现实情况。
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引用次数: 0
A Critical Review on Current Devloping Non-Invasive Glucose Monitoring Technologies and Devices 无创血糖监测技术与设备研究进展综述
Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00044
Ajay I. Patel, Jenish Rachhadiya, Purvi Vadariya, Amitkumar J. Vysh, Ashok B. Patel
Diabetes mellitus both type I and type II, is a dangerous and lifelong disorder marked by unusually high blood glucose levels caused by a failure of insulin synthesis or a loss in insulin sensitivity and function. Diabetes have become more common over time, and it is now considered one of the primary causes of high death and morbidity rates. Complications from diabetes can be avoided by regularly monitoring and keeping blood glucose levels within the normal range. Despite the fact that practically all commercially effective blood glucose monitoring devices are invasive, there is an urgent need to create non-invasive glucose monitoring (NGM) devices that would relieve diabetics' pain and suffering associated with repeated skin pricking for glucose testing. It also discusses the most common non-invasive glucose monitoring technologies as well as the most relevant devices. The technology name, the underlying physical principle, and the technological limitation in the human body. There are eleven technologies and five devices in all. Despite numerous fascinating and promising ideas and devices, the review concluded that a suitable solution to the non-invasive glucose monitoring problem still required more work.
1型和2型糖尿病是一种危险的终身疾病,其特征是由胰岛素合成失败或胰岛素敏感性和功能丧失引起的异常高血糖水平。随着时间的推移,糖尿病变得越来越普遍,现在被认为是高死亡率和高发病率的主要原因之一。糖尿病的并发症可以通过定期监测和保持血糖水平在正常范围内来避免。尽管实际上所有商业上有效的血糖监测设备都是侵入性的,但迫切需要创造一种非侵入性血糖监测(NGM)设备,以减轻糖尿病患者因反复刺破皮肤进行血糖测试而带来的疼痛和痛苦。它还讨论了最常见的无创血糖监测技术以及最相关的设备。技术名称,潜在的物理原理,以及在人体中的技术限制。总共有11种技术和5种设备。尽管有许多令人着迷和有前途的想法和设备,但该综述得出的结论是,非侵入性血糖监测问题的合适解决方案仍需要更多的工作。
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引用次数: 0
Method Development using a UV Visible Spectrophotometer for the Simultaneous Estimation of Metformin (MET), Saxagliptin (SXG), and Dapagliflozin (DGF) in Marketed Formulation 采用紫外可见分光光度计同时测定上市制剂中二甲双胍(MET)、沙格列汀(SXG)和达格列净(DGF)的含量
Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00039
Priya Barbude, M. Tawar, Prashant J. Burange
Type 2 diabetes mellitus (T2DM) is a disorder distinguished by resisting insulin effects and/or its reduced secretion leading to high blood sugar levels. It is fast becoming epidemic worldwide and is a major cause of death in the past years. Maintaining a correct blood sugar level is the primary target in the management of T2DM. Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A complexation, derivatization, extraction, evaporation and sensitive-free direct a new, simple, precise, accurate, reproducible, and efficient UV spectrophotometric method is developed and validated for the simultaneous estimation of ternary mixture of metformin (MET), saxagliptin (SXG) and dapagliflozin (DGF) in both their bulk form and combined in tablet dosage form recently approved by FDA in 2019 to be used for treatment of Type 2 diabetes mellitus by simultaneous equation method. The solutions of standard and sample were prepared in methanol: water (80:20 v/v). The 𝜆max for MET, SXG, and DGF were 232.0, 212.0 and 272.0nm, respectively. Calibration curves are linear in the concentration ranges 10-50𝜇g/ml for MET, 1-5𝜇g/ml for SXG and 5-25𝜇g/ml for DGF, respectively. Results of analysis of simultaneous equation method were analyzed and validated for various parameters according to ICH guidelines.
2型糖尿病(T2DM)是一种以抵抗胰岛素作用和/或胰岛素分泌减少导致高血糖水平为特征的疾病。它在世界范围内迅速流行,是过去几年死亡的一个主要原因。维持正确的血糖水平是T2DM管理的首要目标。开发一种单一的分析方法来从多药组合物中估计单个药物是一项非常具有挑战性的任务。建立了一种新的、简单、精确、准确、可重复、高效的紫外分光光度法,用于同时测定FDA于2019年批准用于治疗2型糖尿病的二甲双胍(MET)、沙格列汀(SXG)和达格列净(DGF)三联制剂的原药和片剂。用甲醇:水(80:20 v/v)配制标准品和样品溶液。MET、SXG和DGF的𝜆max分别为232.0、212.0和272.0nm。MET浓度范围为10-50𝜇g/ml, SXG浓度范围为1-5𝜇g/ml, DGF浓度范围为5-25𝜇g/ml,校准曲线呈线性关系。根据ICH指南对联立方程法的分析结果进行了分析和验证。
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引用次数: 0
Application of PLS and PCR as Multivariate Calibration Techniques for Simultaneous Estimation of Ofloxacin and Ornidazole in Binary Mixtures PLS和PCR作为二元混合物中氧氟沙星和奥硝唑同时测定的多元校准技术的应用
Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00037
A. Sutar, M. B. Mangsule
Two chemometric methods PLS and PCR were used to simultaneously estimate Ofloxacin and Ornidazole in binary mixtures. Mean centering is used as a preprocessing tool and then PLS and PCR models were built with help of calibration and validation set. These methods showed good results for validation parameters including accuracy, precision, linearity, robustness etc. at the same time lower values of RMSEP, PRESS and RMSECV shows statistical significance of the developed methods. Results show that multivariate calibrations techniques can be successfully used to analyses Ofloxacin and Ornidazole in pharmaceutical formulations.
采用PLS和PCR两种化学计量方法同时测定氧氟沙星和奥硝唑的含量。采用均值定心作为预处理工具,利用校正和验证集建立PLS和PCR模型。这些方法在准确度、精密度、线性度、鲁棒性等验证参数上均取得了较好的效果,同时RMSEP、PRESS和RMSECV的较低值均具有统计学意义。结果表明,多元校正技术可成功地用于药物制剂中氧氟沙星和奥硝唑的分析。
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引用次数: 0
Development of HPLC Fingerprinting Method via Estimation of Piperine for Unani Formulation Hab-e-Azarakhi HPLC指纹图谱法测定乌纳尼复方苦参中胡椒碱含量的建立
Pub Date : 2022-11-23 DOI: 10.52711/2231-5675.2022.00042
T. Jain, A. Vyas, D. Dubey, K. Dashora, Vishal Jain
Hab-e-Azarakhi is an important Unani formulation, is official in Unani Pharmacopoeia. The formulation is dispensed for the tone up the nervous system and liver. It is also useful for increase the appetite. Fingerprinting of active principles through modern analytical tools is essential for establishing the authenticity, creditability, prescription and usage of Traditional medicines/herbal formulations. Selective and efficient analytical methods are required not only for quality assurance but also for authentication of herbal formulations. The present study is an attempt to develop Fingerprint method for Hab-e-Azarakhi with High Performance Liquid chromatography (HPLC) using piperine as a standard was developed. The estimation was carried out with three laboratory batches and one marketed formulation of Hab-e-Azarakhi. The concentration of piperine content of Hab-e-Azarakhi (three laboratory batches) and powdered Piper nigrum and Piper longum was carried out separately. The concentration of piperine present in raw material was found to be 2.9876±0.837%w/w in Piper nigrum and 0.9363±0.167% w/w in Piper longum and in three identical laboratory batches of Hab-e- Azarakhi HA-I, HA-II and HA-III 1.8121±0.739%, 1.8806±0.439%, 1.8901±0.779% w/w respectively, while in M-I it was 1.2108 ± 0.182%. The developed HPLC method is simple, rapid, precise and accurate for routine estimation piperine in Hab-e- Azarakhi.
乌纳尼药典是乌纳尼的一种重要制剂。这个配方是用来调节神经系统和肝脏的。它也有助于增加食欲。通过现代分析工具对活性成分进行指纹识别对于确定传统药物/草药配方的真实性、可信度、处方和用法至关重要。选择性和高效的分析方法不仅需要质量保证,也需要草药配方的认证。建立了以胡椒碱为标准品的高效液相色谱指纹图谱方法。用3个实验室批次和1个市售制剂进行了估计。分别测定了3个实验室批次的苦参、胡椒粉和长胡椒粉的胡椒碱含量。原料中胡椒碱的含量分别为:黑椒(Piper nigrum) 2.9876±0.837%w/w,长椒(Piper longum) 0.9363±0.167% w/w, Hab-e- Azarakhi HA-I、HA-II和HA-III三个实验室批次分别为:1.8121±0.739%、1.8806±0.439%、1.8901±0.779% w/w, M-I为:1.2108±0.182%。所建立的高效液相色谱法简便、快速、精密度高、准确度高,可用于中药中胡椒碱的常规测定。
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引用次数: 0
A Brief Review on Liquid Chromatography-Mass Spectrometry/LCMS and its Application 液相色谱-质谱联用技术及其应用综述
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00034
Amit Kumar J. Vyas, Sonali B. Mishra, A. Patel, N. K. Patel, S. R. Shah, D. Sheth
Liquid Chromatography- Mass Spectrometry is a powerful analytical technique having high Sensitivity and Specificity. LC-MS combines the separation capabilities of Liquid Chromatography with the mass analysis capabilities of Mass Spectrometry. Liquid Chromatography separates the mixture, which is having multiple components, and then Mass Spectrometry provides the Spectral information which is used to identify each separated component. Interfaces are used in LC-MS system to transfer the maximum amount of analyte, remove a significant portion of the mobile phase, and preserves the chemical identity. Different types of Interfaces are used which include Atmospheric-Pressure Ionization, Electrospray Ionization, Atmospheric Pressure Chemical Ionization, Thermospray and Plasma Spray Ionization, Particle Beam Ionization, Continuous Flow Fast Atom Bombardment. LC-MS having a wide range of application in various field which include Pharmaceutical, Drug Development, Forensic Science, Cosmetic, Petrochemistry, Environment, Food Analysis, Biochemical Application. In this article Principle, Instrument and Application are discussed briefly.
液相色谱-质谱法是一种强大的分析技术,具有高灵敏度和特异性。LC-MS结合了液相色谱的分离能力和质谱的质量分析能力。液相色谱法分离混合物,其中有多种成分,然后质谱法提供光谱信息,用于识别每个分离的成分。在LC-MS系统中使用接口来转移最大量的分析物,去除大部分流动相,并保持化学特性。使用不同类型的界面,包括大气压电离,电喷雾电离,大气压化学电离,热喷雾和等离子体喷雾电离,粒子束电离,连续流快速原子轰击。LC-MS在制药、药物开发、法医学、化妆品、石油化学、环境、食品分析、生化等领域有着广泛的应用。本文对其原理、仪器及应用作了简要论述。
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引用次数: 2
A Brief Review on Pharmaceutical Validation 药品验证技术综述
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00035
Darshan A. Salade, Kishor S. Arote, P. Patil, Vikas V. Patil, Amol R. Pawar
Validation is the procedure which authorizing documentary evidence that proves the following process will consistently produce the product which leads to the expected result. According to GMP validation studies are important part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. Validation is the one of the important part in achieving and maintaining the quality of the final product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Process validation is an integral part of quality assurance as per cGMP. Validation and quality assurance will go hand in hand, ensuring the thorough quality for product. Process validation plays a key role in the pharmaceutical manufacturing process as it delivers a high degree of assurance and evidence that the process, which is being carried out gives out the uniform results, that is, it means the required specifications, which has been performed accurately. The purpose of this review is to present an introduction and general review on validation in pharmaceutical industry.
验证是授权书面证据的程序,证明以下工艺将始终如一地生产导致预期结果的产品。根据GMP验证研究是GMP的重要组成部分,这些研究需要按照预定义的协议进行,至少应该验证的内容包括工艺,测试和清洁,因此建立控制程序以监控可能导致药品变异性的生产工艺的输出和验证。验证是实现和保持最终产品质量的重要环节之一。验证研究提供了公司所采用的检测方法的准确性、灵敏度、特异性和可重复性,应建立并形成文件。工艺验证是提高制药工业生产的剂型的安全性和质量的过程。根据cGMP,工艺验证是质量保证的一个组成部分。验证和质量保证将齐头并进,确保产品的全面质量。工艺验证在药品生产过程中起着关键作用,因为它提供了高度的保证和证据,证明正在实施的工艺给出了统一的结果,也就是说,它意味着要求的规范已经准确地执行了。本综述的目的是介绍和概述制药行业的验证。
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引用次数: 0
期刊
Asian Journal of Pharmaceutical Analysis
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