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UV Spectrophotometric and HPLC Method for Quantification of Ticagrelor in Bulk and Tablet Dosage Form 紫外分光光度法和高效液相色谱法测定替格瑞洛原料药和片剂的含量
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00027
Ravinder Bairam, Hemant Kumar Tatapudi, Neelama Gajji, Shaik Harun Rasheed
The aim of the present investigation was to develop, validate and compare a UV spectrophotometric and a high performance liquid chromatography method for estimating Ticagrelor in bulk and tablet dosage form. Spectrophotometry and high performance liquid chromatography were carried out using standard instrumental parameters, which were optimized. Both methods were validated in terms of linearity, accuracy, precision, robustness, ruggedness and stability according to the ICH guidelines. The optimized ratio of mobile phase in high performance liquid chromatography under low pressure gradient mode was 30:70 % v/v of acetonitrile:glacial acetic acid 1 % , which provide a sharp peak with a short retention time of 3.910 minutes. In UV spectrophotometric analysis iso-propyl alcohol as a solvent gave adequate molar absorptivity at a λmax of 306 nm. Results indicated that both UV spectrophotometric and high performance liquid chromatography methods were linear, precise, accurate, rugged and robust with RSD values less than 2 % and percent recovery was within the standard limits (90-110 %). Both the methods were found to be statistically non-significant at 95 % confidence intervals (p<0.05) with respect to each other. The proposed methods were found to be highly effective and could be used for quantification of Ticagrelor in bulk and a tablet formulations for routine analysis.
本研究的目的是建立、验证和比较紫外分光光度法和高效液相色谱法对替格瑞洛散装剂型和片剂剂型的估计。采用标准仪器参数进行分光光度法和高效液相色谱法测定。根据ICH指南对两种方法在线性、准确度、精密度、稳健性、坚固性和稳定性方面进行了验证。在低压梯度模式下,高效液相色谱的最佳流动相比为:乙腈:冰醋酸:冰醋酸:30:70 % v/v,峰形清晰,保留时间短,为3.910 min。在紫外分光光度分析中,异丙醇作为溶剂有足够的摩尔吸收率,λmax为306 nm。结果表明,紫外分光光度法和高效液相色谱法线性良好,精密度高,准确度高,RSD值小于2%,回收率在标准范围内(90 ~ 110%)。两种方法在95%置信区间(p<0.05)均无统计学意义。结果表明,该方法有效,可用于替格瑞洛原料药的定量分析和替格瑞洛片剂的常规定量分析。
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引用次数: 3
Development and Validation of an RP-HPLC Method for the determination of Safinamide Mesylate in Bulk and Pharmaceutical Dosage Form 反相高效液相色谱法测定甲磺酸沙非胺原料药和制剂含量的建立与验证
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00029
A. Rehman, Pasupathi Nath Tiwari, Sreenivasa Rao
A rapid and highly sensitive high performance liquid chromatographic method has been developed for the determination of Safinamide Mesylate in bulk and in tablet dosage form. Safinamide mesylate was eluted from a XBridge C18 (250mmX4.6mm) reversed phase column with a mobile phase of Ammonium acetate buffer pH 5.8 and Acetonitrile in the ratio of 55:45 (v/v) at a flow rate of 1ml/min with UV detection of 26nm. The retention time for Safinamide mesylate was 3.8min. The linear response (r2 = 0.997) was observed in the range of 10-60 µg/ml with limits of detection (LOD) and quantification (LOQ) being 2.85 and 9.5µg/ml respectively. The method shows good recoveries and intra and inter-day relative standard deviations were less than 2%. Validation parameters as Specificity, accuracy, ruggedness and robustness were also determined. The proposed method provides accurate and precise quality control tool for routine of Safinamide mesylate in bulk and in tablet dosage form.
建立了一种快速、高灵敏度的高效液相色谱法测定甲磺酸沙芬酰胺原料药和片剂的含量。采用XBridge C18 (250mmX4.6mm)反相色谱柱洗脱甲磺酸沙芬酰胺,流动相为醋酸铵缓冲液pH为5.8,乙腈为55:45 (v/v),流速为1ml/min,紫外检测波长为26nm。甲磺酸沙芬胺的保留时间为3.8min。在10 ~ 60µg/ml范围内线性响应(r2 = 0.997),检出限(LOD)和定量限(LOQ)分别为2.85和9.5µg/ml。方法回收率高,日内、日间相对标准偏差均小于2%。确定了特异性、准确性、坚固性和稳健性等验证参数。该方法为甲磺酸沙芬胺原料药和片剂的质量控制提供了准确、精确的方法。
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引用次数: 0
A Review on Pharmaceutical Cleaning Validation 药品清洗验证技术综述
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00033
Darshan A. Salade, Kishor S. Arote, P. Patil, Pankaj S. Patil, Amol R. Pawar
The goal of this review is to establish the significance of cleaning validation in the pharmaceutical industry. Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. Cleaning procedure is the process of assuring that cleaning procedures effectively remove the potentially dangerous substances from equipments. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. It briefly provides an overview on mechanism of contamination, cleaning mechanisms, cleaning agents, procedure of cleaning, and sampling techniques.
本综述的目的是建立清洁验证在制药工业中的意义。药品和活性药物成分(原料药)可能被其他药品或原料药、清洗剂、微生物或其他物质(如空气中的颗粒、灰尘、润滑剂、原料、中间体等)污染。清洁程序是确保清洁程序有效地从设备中去除潜在危险物质的过程。这可以通过适当清洁设备,仪器以及加工区域来最小化。因此,有必要对清洗程序进行验证,以确保后续批次药品的安全性、有效性和质量,并满足药品生产中的法规要求。它简要地概述了污染的机理、清洗机理、清洗剂、清洗程序和取样技术。
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引用次数: 1
Analytical Method Development and Validation of Teriflunomide Active Pharmaceutical Ingredient by RP-UHPLC 特立氟米特有效成分反相高效液相色谱分析方法的建立与验证
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00028
Arun Maruti Kashid, Pranali Prakash Polshettiwar, Kshitija Maruti Bhosale
Drug analysis is crucial in the discovery, production, and therapeutic use of pharmaceuticals. Standard analytical procedures for newer medications or formulations may not be available in Pharmacopoeias; thus, newer analytical methods that are accurate, precise, specific, linear, simple, and rapid must be developed. A rapid, simple, sensitive, precise, and cost-effective RP-UHPLC method was developed and validated for the determination of Teriflunomide Active Pharmaceutical Ingredient (API) in this study. The method involved determination of Teriflunomide by resolving on RP-UHPLC using Sunniest C18 (250mm × 4.6mm, 5μm) column, utilizing a mobile phase of ACN: Water in the ratio of 60:40 v/v. The mobile phase was delivered with an isocratic flow rate of 1.0ml/minute. Ultra violet detection was carried out at 210nm. The retention time was optimized to 4. 4 minutes. The linearity range of Teriflunomide 35 to 247µg/ml was found to obey linearity with a correlation coefficient of 0.999. The LOD and LOQ were found to be 1.61µg/ml and 4.90µg/ml respectively and precision data was found to be <2 %RSD. The percentage recovery range was found to be satisfied which is represented in the results. The robustness studies were performed by changing the flow rate and mobile phase compositions. The method was validated for system suitability, specificity, linearity, precision, accuracy, Limit of Detection, Limit of Quantification and robustness. The developed method can be applied for the quality control of commercial teriflunomide API.
药物分析在药物的发现、生产和治疗使用中是至关重要的。药典中可能没有新药物或新制剂的标准分析方法;因此,必须发展准确、精确、专一、线性、简单、快速的新型分析方法。建立了一种快速、简便、灵敏、精确、经济高效的特立氟米特原料药(API)的反相高效液相色谱测定方法。采用反相高效液相色谱法测定特立氟米特,色谱柱为Sunniest C18 (250mm × 4.6mm, 5μm),流动相为ACN: Water,比例为60:40 v/v。流动相以等压流速1.0ml/min给药。在210nm处进行紫外检测。最佳保留时间为4小时。4分钟。特立氟米特浓度在35 ~ 247µg/ml范围内呈线性关系,相关系数为0.999。定量限和定量限分别为1.61µg/ml和4.90µg/ml,精密度RSD < 2%。结果表明,回收率范围满足要求。通过改变流速和流动相组成进行稳健性研究。验证了该方法的系统适用性、专属性、线性度、精密度、准确度、检出限、定量限和鲁棒性。该方法可用于特立氟米特原料药的质量控制。
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引用次数: 1
Development and Validation of UV Spectrophotometric Methods for Simultaneous Estimation of Dolutegravir Sodium and Rilpivirine Hydrochloride in Pure Bulk Form 紫外分光光度法同时测定多替格拉韦钠和盐酸利匹韦林纯度的方法建立与验证
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00031
Sandip T. Thoke, Umesh T. Jadhao, Gunesh N. Dhembre
A simple, specific, sensitive, rapid, precise, accurate and economical UV Spectrophotometric simultaneous equation method have been developed and validated for the routine estimation of Dolutegravir sodium and Rilpivirine Hydrochloride in bulk form. The Method A employs estimation of drugs by simultaneous equation method (SEM) using synthetic mixture of drugs. The absorption maxima of drugs were found to be at 259.20nm for Dolutegravir sodium and 305.80nm for Rilpivirine Hydrochloride. Both drugs followed the beer lamberts law in the range of 4-24µg/ml and 1-8µg/ml for DOL and RIL respectively. Methods are validated according to ICH guidelines and can be adopted for the routine analysis Dolutegravir sodium and Rilpivirine Hydrochloride in pure bulk form.
建立了一种简便、特异、灵敏、快速、精确、准确、经济的紫外分光光度联立方程法,用于定量测定多替格拉韦钠和盐酸利匹韦林的含量。方法A采用药物合成混合物联立方程法(SEM)对药物进行估计。多替格拉韦钠的吸光度最大值为259.20nm,盐酸利匹韦林的吸光度最大值为305.80nm。两种药物的DOL和RIL分别在4 ~ 24µg/ml和1 ~ 8µg/ml范围内符合beer lamberts定律。方法根据ICH指南进行验证,可用于常规分析纯散装多替格拉韦钠和盐酸利匹韦林。
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引用次数: 2
A Brief Review on Titanium Dioxide 二氧化钛的研究进展
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00032
Disha L. Barad, Urvi J. Chotaliya, Nilesh K. Patel
Titanium Dioxide (TiO2) is widely used in food products and can be found in sauces, icings, and chewing gums as well as in personal care products such as pharmaceutical tablets and toothpaste. Tio2 particle added as a whitening agent to confectionary products, that is, chewing gum, candies, chocolate, and snacks. Titanium dioxide is found naturally in various crystal phases. It exists in different crystal structures. anatase, rutile, and brookite, or a mixture of these. The major routes of TiO2 NP exposure that have toxicological relevance in humans are inhalation, dermal, and oral exposure. for characterization of particle size, size distribution, crystallinity, and concentration of Tio2 particles were first extracted using an acid digestion method from food and separation, various analytical methods were applied. The present study focus on the analyzes qualitative and quantitative trace element by using some analytical methods. TiO2 levels of investigated foods were determined by UV Spectroscopy, Inductively coupled plasma optical emission spectroscopy (ICP-OES), X-ray photoelectron spectroscopy, UV-Visible diffuse reflectance, Raman spectroscopy, Electron microscopy, X-ray diffraction (XRD), Gas volumetry, Laser diffraction, Laser droppler electrophorosis, FT-Raman, Spectroscopic analysis.
二氧化钛(TiO2)广泛用于食品中,可以在酱汁、糖霜、口香糖以及个人护理产品(如药片和牙膏)中找到。二氧化钛颗粒作为增白剂添加到糖果产品中,即口香糖、糖果、巧克力和零食中。二氧化钛在自然界中以各种晶体相存在。它存在于不同的晶体结构中。锐钛矿、金红石和蓝铜矿,或它们的混合物。对人类具有毒理学相关性的TiO2 NP暴露的主要途径是吸入、皮肤和口服暴露。为了表征Tio2颗粒的粒度、粒度分布、结晶度和浓度,首先采用酸消化法从食物中提取Tio2颗粒并进行分离,应用了多种分析方法。本研究的重点是利用一些分析方法对痕量元素进行定性和定量分析。采用紫外光谱法、电感耦合等离子体发射光谱法(ICP-OES)、x射线光电子能谱法、紫外-可见漫反射光谱法、拉曼光谱法、电子显微镜法、x射线衍射法(XRD)、气体体积法、激光衍射法、激光滴管电泳法、傅里叶变换拉曼光谱法(FT-Raman)、光谱分析等方法测定食品中TiO2的含量。
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引用次数: 0
Detection of Nicotine by a New System: 一种新的尼古丁检测系统:
Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00030
Kamalakshi Krishnamurthy, T. Zin., Priyamvatha K., Mahadeva Rao. U. S., S. M.
Nicotine (C10 H14 N2) exists in all parts of the plant but notably in the leaves. Nicotiana tabacum, or cultivated tobacco, is an annually grown herbaceous plant of the Nicotiana genus. In this study a rapid and sensitive evaluation of Nicotine by Thin Layer Chromatography is carried out.
尼古丁(C10 H14 N2)存在于植物的所有部位,但主要存在于叶片中。烟草(Nicotiana tabacum),或栽培烟草,是烟草属的一年生草本植物。本研究采用薄层色谱法对尼古丁进行了快速、灵敏的评价。
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引用次数: 0
Implementation of QBD Approach in Analytical Method Development of Fluvastatin by UV-VIS Spectrophotometry QBD法在氟伐他汀紫外-可见分光光度法分析方法开发中的应用
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00016
G. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar
Quality by design (QbD) is a systematic process for pharmaceutical development recommended by regulatory agencies like USFDA. Development of various pharmaceutical processes including analytical methods by applying Quality by design aids in ensuring the robustness of the method. An analytical method was developed for the estimation of fluvastatin by applying QbD approach by UV-VIS spectrophotometry. Solvent 0.1 N NaOH was utilised and 302.4 nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of the drugs was ascertained over the conc range 5-40 mcg/ml (microgram/ml). The accuracy was found within acceptable limit with SD 0.05079-0.78188 %; and the precision study was shown acceptable data as % RSD 0.6259-0.6559 for FVT. The stability of the method was studied by minor variation in the wavelength and minor change in the normality of solvent. The developed method is rigid, robust and efficient for the estimation of FVT from the dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage. The analytical methods, developed based on the QbD concept are more robust and reduce the number of out of trend (OOT) and out of specification (OOS) results during the actual usage in quality control.
质量设计(QbD)是美国fda等监管机构推荐的药物开发系统过程。通过应用设计质量来开发各种制药工艺,包括分析方法,以确保方法的稳健性。建立了紫外-可见分光光度法定量测定氟伐他汀的分析方法。溶剂为0.1 N NaOH,吸光度测量波长为302.4 nm。研究了输入变量对光谱特征的影响,以选择关键参数,并根据ICH q2 R1监管指南验证了所开发的方法。在5-40 mcg/ml(微克/ml)范围内确定了药物的线性关系。准确度在可接受范围内,SD为0.05079 ~ 0.78188%;精密度研究显示,FVT的% RSD为0.6259-0.6559,可接受。通过波长的微小变化和溶剂正态性的微小变化来考察该方法的稳定性。该方法具有刚性、鲁棒性和效率高的特点。通过前期的风险评估和后期的设计空间界定,将QbD应用于构建刚性稳健方法。基于QbD概念开发的分析方法更具鲁棒性,在实际质量控制使用过程中减少了不合趋势(OOT)和不合规格(OOS)结果的数量。
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引用次数: 0
Development and Validation of Novel UV Spectroscopy Method for the Estimation of L-Glutathione in Bulk and Formulation with Congo Red 新型紫外光谱法测定原料药和刚果红制剂中l -谷胱甘肽含量的建立与验证
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00014
G. Gajeli, S. Kumbhar, G. Patel
A novel UV-Spectroscopy method was developed and validated for the estimation of L-glutathione in bulk and dosage form with congo red. The wavelength at which L-glutathione and congo red mixture product showed maximum absorption at 568nm in distilled water. The developed method range was found to be10-90µg/ml. The developed method validated for linearity, precision, range, limit of detection, the limit of quantification, robustness, specificity, system suitability. The regression equation was found to be y = 0.0045x + 0.121 with correlation coefficient R² = 0.9983. The limit of detection and the quantification limit was 5.05 µg/ml and 15.32 µg/ml respectively. The developed method was found to be linear, precise, robust, economical for the evaluation of L-glutathione in bulk and dosage form.
建立了用刚果红测定l -谷胱甘肽原料药和剂型的紫外光谱分析方法。l -谷胱甘肽与刚果红混合产物在蒸馏水中的最大吸收波长为568nm。所建立的方法范围为10 ~ 90µg/ml。该方法对线性度、精密度、范围、检出限、定量限、鲁棒性、特异性和系统适用性进行了验证。回归方程为y = 0.0045x + 0.121,相关系数R²= 0.9983。检测限为5.05µg/ml,定量限为15.32µg/ml。该方法线性、准确、可靠、经济,可用于l -谷胱甘肽原料药和剂型的定量评价。
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引用次数: 0
Analytical Methods for Estimation of Curcumin in Bulk, Pharmaceutical Formulation and in Biological Samples 散装、制剂和生物样品中姜黄素含量的分析方法
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00025
Ganesh R. Bharskar, S. Mankar, S. Siddheshwar
Curcumin natural chemical constituents extracted from Curcuma longa has been extensively studied because of its various pharmacological properties, such as anti-inflammatory, antioxidant, anti-proliferative, antitumor, antibiotic, antiprotozoal, immunomodulatory and anticarcinogenic effects. Analytical methods play an important role to describe physicochemical properties of drug. Several techniques for estimating curcumin in turmeric powder and pharmaceutical formulations have been developed to improve the demand for analytical methods of curcumin. Various analytical methods for estimating curcumin (spectrophotometric, chromatographic, capillary electrophoresis, and biosensor approaches) have been fully reviewed and discussed in this study.
姜黄素是一种从姜黄中提取的天然化学成分,因其具有抗炎、抗氧化、抗增殖、抗肿瘤、抗生素、抗原虫、免疫调节和抗癌等多种药理作用而受到广泛研究。分析方法在描述药物的理化性质方面起着重要作用。为了提高对姜黄素分析方法的要求,人们开发了几种测定姜黄粉和制剂中姜黄素含量的技术。本文对姜黄素的各种分析方法(分光光度法、色谱法、毛细管电泳法和生物传感器法)进行了全面的综述和讨论。
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引用次数: 0
期刊
Asian Journal of Pharmaceutical Analysis
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