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A Stability Indicating Reverse Phase-HPLC method development and Validation for the Estimation of Bimatoprost 0.3% &Timolol 0.5% Pharmaceutical Ophthalmic Dosage Form

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American Journal of Analytical Chemistry 2022年第12期13卷 506-530页

作者： Md. S. Amin Muhammad T. Islam Department of Pharmacy University of Development Alternative Dhaka Bangladesh Department of Pharmacy Long Island University New York USA

The research was carried out to establish a new reverse phase-HPLC stability indicating method for quantifying Bimatoprost & Timolol in ophthalmic solution. The experiment of Bimatoprost & Timolol in ophthalmic solution method development was determined on Waters HPLC instrument using a UV Detector. The separation was done by using L11, Zorbex SB phenyl (4.6 mm × 250 mm internal diameter) 5 μm analytical column, containing mobile phase of Phosphate buffer (0.02 M), methanol, and acetonitrile [50:30:20 % v/v]. The method was run at 1 ml·min-1 at 210 nm for Bimatoprost and 295 nm for Timolol for detection. The drug was eluted at 10.81 min for Bimatoprost and 3.77 min for Timolol. After developing the method, it was assured for the intended use by validation, which was done according to ICH Q2B guidelines. The analytical parameters checked were Specificity/Selectivity, linearity, Range, accuracy, ruggedness, and robustness. It was observed that the response of the detector was linear in the range of 6 - 18 μg/ml with a correlation coefficient of 0.999. The results of all the parameters were found to be within the acceptance criteria. The stability-indicating assay method was established by using the samples generated by the forced degradation process. The forced degradation was carried out by subjecting the drug to acid, alkali, thermal, oxidative, and photolytic degradation, and the results showed that the degradation products were successfully separated from the drug. Hence, this can be applied perfectly later for the quantitative analysis of Bimatoprost 0.3% + Timolol 0.5% Ophthalmic Solution drugs for pharmaceutical use. Currently, there is no official method for Bimatoprost & Timolol combination products in USP or BP. Available research work related to single Bimatoprost or Timolol products was not suitable for testing Bimatoprost and Timolol combination drugs. Additionally, there is no stability-indicating method to test Bimatoprost & Timolol combinati

关键词： Bimatoprost Timolol Reverse-Phase High Performance Liquid Chromatography method development Validation Stability Indicating

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Analytical method development and Validation of Some Biosimilar Drugs by High Performance Thin Layer Chromatography

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American Journal of Analytical Chemistry 2023年第3期14卷 121-133页

作者： Husna Kanwal Qureshi Ciddi Veeresham Department of Pharmaceutical analysis University College of Pharmaceutical Sciences Kakatiya University Warangal India

A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica gel 60 F254s HPTLC plates, as stationary phase. The mobile phase optimized for Filgrastim and Etanercept was Water: n-butanol (7.5:2.5 v/v) and Isopropyl alcohol: water (6.5:4.5 v/v), respectively. The chromatogram obtained was scanned at 225 nm and 222 nm for filgrastim and etanercept which resulted in a retention factor of 0.45 ± 0.07 and 0.32 ± 0.03, respectively. The method was validated for parameters like linearity, accuracy, precision, specificity and robustness. Recovery studies were performed at three concentration levels, to demonstrate suitability, accuracy and precision of proposed method. Statistical analysis proved that the proposed method is accurate and reproducible with linearity in the range of 500 to 3000 ng/band for filgrastim and 200 to 1200 ng/band for etanercept. The limit of detection and limit of quantification for filgrastim was found to be 63.418 ng/band and 192.177 ng/band. For etanercept, LOD and LOQ were found to be 33.381 ng/band and 101.153 ng/band, respectively. The proposed method can be employed for the routine analysis of selected biosimilars.

关键词： Biosimilars Etanercept Filgrastim method development Validation

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Robustness Study and Superior method development and Validation for Analytical Assay method of Atropine Sulfate in Pharmaceutical Ophthalmic Solution

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American Journal of Analytical Chemistry 2024年第5期15卷 151-164页

作者： Md. Nazmus Sakib Chowdhury Sreekanta Nath Dalal Md. Ariful Islam Md. Anwar Hossain Pranab Kumar Das Shakawat Hossain Parajit Das Department of Pharmacy Bangabandhu Sheikh Mujibur Rahman Science and Technology University Gopalganj Bangladesh Department of Applied Chemistry and Chemical Engineering University of Dhaka Dhaka Bangladesh Department of Applied Chemistry and Chemical Engineering University of Chittagong Chattogram Bangladesh Department of Applied Chemistry and Chemical Engineering Islamic University Kushtia Bangladesh Department of Applied Chemistry and Chemical Engineering University of Rajshahi Rajshahi Bangladesh Department of Pharmacy International Islamic University Chittagong Chittagong Bangladesh Department of Applied Chemistry and Chemical Engineering Bangabandhu Sheikh Mujibur Rahman Science and Technology University Gopalganj Bangladesh

Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical method variation parameters are based on pH variability of buffer solution of mobile phase, organic ratio composition changes, stationary phase (column) manufacture, brand name and lot number variation;flow rate variation and temperature variation of chromatographic system. The analytical chemical method for assay of Atropine Sulfate conducted for robustness evaluation. The typical variation considered for mobile phase organic ratio change, change of pH, change of temperature, change of flow rate, change of column etc. Purpose: The aim of this study is to develop a cost effective, short run time and robust analytical chemical method for the assay quantification of Atropine in Pharmaceutical Ophthalmic Solution. This will help to make analytical decisions quickly for research and development scientists as well as will help with quality control product release for patient consumption. This analytical method will help to meet the market demand through quick quality control test of Atropine Ophthalmic Solution and it is very easy for maintaining (GDP) good documentation practices within the shortest period of time. method: HPLC method has been selected for developing superior method to Compendial method. Both the compendial HPLC method and developed HPLC method was run into the same HPLC system to prove the superiority of developed method. Sensitivity, precision, reproducibility, accuracy parameters were considered for superiority of method. Mobile phase ratio change, pH of buffer solution, change of stationary phase temperature, change of flow rate and change of column were taken into consideration for robustness study of the developed method. Results: The limit of quantitation (LOQ) of developed method was much low than the compendial method. The % RSD fo

关键词： Robustness method Validation HPLC Compendial method method development GDP LOQ

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A Stability Indicating Reverse Phase-HPLC method development and Validation for the Estimation of Rucaparib in Bulk and Pharmaceutical Dosage Form

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American Journal of Analytical Chemistry 2021年第4期12卷 96-107页

作者： D. Suchitra Satyanarayana Battu Department of Pharmacy University College of Technology Osmania University Hyderabad India Department of Chemistry University College of Science Osmania University Hyderabad India

The research was carried out for establishing a new reverse phase-HPLC stability indicating method for the quantification of Rucaparib. The experiment was determined on Waters HPLC instrument using 996 photo-diode array detector. The separation was done by using symmetry C-18 ODS (25 cm × 0.46 cm internal diameter) 5 μm analytical column containing mobile phase of Phosphate buffer (0.02 M) and methanol [65:35% v/v] adjusted pH to 4.8 by adding dilute ortho phosphoric acid. The method was run at 1 ml·min-1 at 286 nm detection. The drug was eluted at 5.484 min. After developing the method, it was assured for the intended use by validation which was done according to ICH Q2B guidelines. The analytical parameters checked were linearity, accuracy, repeatability, intermediate precision, limit of detection, limit of quantitation, ruggedness and robustness. It was observed that the response of the detector was linear in the range of 6 - 14 μg/ml with correlation coefficient of 0.999. The results of all the parameters were found to be within the acceptance criteria. The stability indicating assay method was established by using the samples generated by forced degradation process. The forced degradation was carried out by subjecting the drug to acid, alkali, thermal, oxidative and photolytic degradation and the results showed that the degradation products were successfully separated from the drug. Hence, this can be applied perfectly later for the analysis of quality of the rucaparib drug.

关键词： Rucaparib Reverse-Phase High Performance Liquid Chromatography method development Validation

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Analytical method development and Validation of Filgrastim by UV and RP-UFLC methods

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American Journal of Analytical Chemistry 2021年第10期12卷 333-346页

作者： Husna Kanwal Qureshi Ciddi Veeresham Chinta Srinivas Department of Pharmaceutical Analysis University College of Pharmaceutical Sciences Kakatiya University Warangal India

The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar drug, Filgrastim. Filgrastim or recombinant methionyl granulocyte colony stimulating factor (rGCSF) is a glycoprotein. It has a biological action essential for proliferation and differentiation of hematopoetic and progenitor cells. The UV and RP-UFLC work was carried on a Shimadzu UV1800 Spectrophotometer and Shimadzu Prominence LC-20AD UFLC systems, respectively. The λmax of filgrastim was found to be 215 nm. The correlation coefficient by UV spectroscopy was found to be 0.9994 for the concentration range of 1 to 3 μg/ml in double distilled water. The Reverse phase UFLC was done by using Phenomenex C4 (25 cm × 0.46 cm internal diameter) 15 μ, 300 A° analytical column. The optimized mobile phase for binary elution was Acetonitrile and double distilled water (80:20) with a flow rate of 1 ml/min. The retention time of drug was at 3.2 min. It was observed that the response of the detector was linear in the range of 5 - 15 μg/ml with correlation coefficient value of 0.999. After developing the methods, it was assured for the intended use by validation of the analytical parameters like linearity, accuracy, precision, limit of detection, limit of quantitation, ruggedness and robustness. The results of all the parameters for both the methods were found to be within the acceptance criteria as per the International Council for Harmonisation (ICH) guidelines.

关键词： Biosimilars Filgastim method development RP-UFLC UV Visible Spectroscopy Validation

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development of a rapid GC-FID method to simultaneously determine triethylamine, diisopropylamine, and 1,1,3,3-tetramethylguanidine residues in an active pharmaceutical ingredient

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Journal of Pharmaceutical Analysis 2021年第2期11卷 251-256页

作者： Minshan Shou Haixiao Qiu Analytical Research and development Abbvie Inc.North ChicagoIL60064USA

A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical ingredient(API). Due to the severe absorption of amines on GC stationary phases,GC columns with various stationary phases were evaluated for optimal peak shape and *** final conditions used the Agilent CP-Volamine column to resolve the three amines in 12 min. Various inlet liners were also screened to further improve the sensitivity of the analysis. The Restek Siltek~? liner was selected to achieve the desired detectability for the method. The quantitation limits were 4, 3, and 4 mg/mL for TEA, DIPA, and TMG in the presence of API, respectively. All three amines showed good linearity(r > 0.999) and recoveries(> 90%) over the concentration range of 3 to 16 mg/mL. The testing of residual amines was initially performed at the penultimate stage of the synthesis. However, this work demonstrates that TMG can act as a proton sponge to react with salicylic acid, the counter ion of the penultimate, to form a volatile component that elutes at a different retention time. Consequently, in the final method, these three amines were monitored in the final API to circumvent the matrix *** parameters of the method were qualified per method validation requirements in ICH guidelines. The method was successfully applied for batch testing during development and implemented as an inprocess control procedure at manufacturing sites.

关键词： GC-FID Amines API method development method qualification

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Quality Control of Tramadol in Kisangani: development, Validation, and Application of a UV-Vis Spectroscopic method

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American Journal of Analytical Chemistry 2021年第8期12卷 295-309页

作者： Marguerite Borive Amani Jérémie Mbinze Kindenge Emile Tweni Baruti Elodie Nsasi Bakiantima Salomon Batina Agasa Philippe Hubert Roland Marini Djang’eing’a Department of Pharmacy Faculty of Medicine and Pharmacy University of Kisangani Kisangani Democratic Republic of the Congo Laboratory of Drugs Analysis Department of Galenic and Drug Analysis Faculty of Pharmaceutical Sciences University of Kinshasa Kinshasa Democratic Republic of the Congo Department of Internal Medicine Faculty of Medicine and Pharmacy University of Kisangani Kinshasa Democratic Republic of the Congo Laboratory of Analytical Pharmaceutical Chemistry Faculty of Medicine University of Liège Liège Belgium

Context: Substandard and falsified medicines are circulating in low-income countries mostly without any control. We availed a simple and not expensive UV-Vis spectroscopic method to evaluate the quality of tramadol in Kisangani before and during the Covid-19 period. methods: For the analytical quantitative method, an experimental design was applied to set up the optimal levels of the selected factors, namely, pH of dissolution medium, type of cuvette, and wavelength. Taking into account the capsule pharmaceutical formulation within 80 - 120 μg·mL-1 concentration range, we analyzed 89 tramadol samples from pharmacies and hospitals of the six Kisangani municipalities. Results: pH showed a significant effect on absorbance, whereas quartz cuvette and wavelength did not. A typical 100 μg·mL-1 tramadol solution gave an absorbance of 0.64 at 272 nm. Validation highlighted a matrix effect observed with a 6% bias. A correction factor of 0.9372 allowed to improve the accuracy profile, which were then totally included within the 10% acceptance limits. Quality control revealed that 25 samples out of 89 were not compliant in terms of manufacturing license, registration status in DRC and content as well. Conclusion: This study showed that the strengthening of analytical strategy in Kisangani is a need.

关键词： Tramadol UV-Vis Spectroscopy method development Validation Quality Control

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development and Validation of a UPLC method for the Determination of Docetaxel and Its Related Substances in Pharmaceutical Dosage Forms, an Antineoplastic Agent

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American Journal of Analytical Chemistry 2024年第10期15卷 333-346页

作者： Srinivasulu Kasa Sreenivas Pippalla Mopidevi Narasimha Naidu Dipak Goyal Department of Chemistry Osmania University Hyderabad India Department of Chemistry Sikkim Professional University Gangtok India Dr. Reddys Laboratories Ltd. Hyderabad India Department of Chemistry University of Massachusetts Massachusetts USA

A novel, simple, and sensitive Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantification of process-related impurities and degradants, as well as the assay of Docetaxel. The stability-indicating capability of the method was demonstrated through forced degradation studies and a comprehensive mass balance evaluation. Chromatographic separation was achieved using an ACQUITY UPLC BEH C18 column (100 × 2.1 mm, 1.7 µm), with gradient elution. The mobile phase A comprised a mixture of water, methanol, and acetonitrile (500:300:200, v/v/v), while mobile phase B was acetonitrile and water (800:200, v/v). The flow rate was set at 0.4 mL/min, with detection at 232 nm using a photodiode array detector. The method exhibited excellent performance, with a tailing factor of 1.10 for Docetaxel. The method was rigorously validated for precision, accuracy, linearity, LOD, LOQ, ruggedness, specificity, and robustness. Forced degradation studies confirmed the method’s suitability for stability analysis. Stability testing on the drug substance was conducted following ICH guidelines.

关键词： UPLC method development Validation Docetaxel Impurities ICH

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A Highly Sensitive Kinetic Spectrophotometric System and Its Analytical Potential for Chromatographic Detection of Metal Ions

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Chinese Chemical Letters 1999年第1期10卷 51-54页

作者： Xi Rong HUANG Wen Juan ZHANG Shu Hua HAN Gut Ying XU(College of Chemistry, Shandong University, Jinan 250100) College of Chemistry Shandong University Jinan 250100 China

Based on the inhibitory effect of metal ions on the decolourization reaction of a dye taking place in a mixed micellar medium, a differential rate method was developed for the detection of metal ions. The present kine... 详细信息

关键词： mixed micellar media decolourization reaction bromopyrogallol red metal ions inhibitor spectrophotometry method development

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HPLC-UV method for simultaneous determination of irbesartan, candesartan, gliquidone and pioglitazone in formulations and in human serum

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Journal of Chinese Pharmaceutical Sciences 2018年第4期27卷 273-280页

作者： Agha Zeeshan Mirza Science and Technology Unit Umm Al-Qura University Makah 21955 KSA

In this study, we reported and validated a novel and sensitive reversed-phase liquid chromatographic method for the simultaneous determination of irbesartan, candesartan, gliquidone and pioglitazone. Separation was performed at 230 nm using a mobile phase consisting of methanol–water(90:10, v/v) with a flow rate of 1 mL/min. p H was adjusted to 3.5 with phosphoric acid. The concentration-response relationship was found linear over a concentration range of 5–25 μg/mL for all of the analytes tested. The limits of detection and quantification were 0.83 and 2.78 for irbesartan, 0.30 and 1.01 for candesartan, 1.11 and 3.93 for gliquidone, and 0.41 and 1.41 μg/mL for pioglitazone, respectively. Described method permitted the successful determination of these drugs in human serum. The developed method was simple, rapid, and it did not require extensive sample purification.

关键词： Candesartan Gliquidone Irbesartan Pioglitazone RP-HPLC method development

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