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- Volume 19, Issue 5, 2023
Current Pharmaceutical Analysis - Volume 19, Issue 5, 2023
Volume 19, Issue 5, 2023
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An Overview of Analytical Methods for the Identification and Quantification of Baclofen
Background: Baclofen is a potent antispasmodic agent, acting as an analgesic and central skeletal muscle relaxant. It is a GABA-B analog, and is widely used for the treatment of spasticity. Due to its therapeutic importance, various analytical techniques are used in the pharmaceutical industry and research to determine, identify, and characterize baclofen in bulk material, biological fluids, and pharmaceutical forms. Objective: This review aimed to collect information on reported analytical techniques commonly used to identify and quantify baclofen in pharmaceutical forms and biological samples. Methods: The authors explored various authenticated scientific journals using these descriptors: highperformance liquid chromatography, liquid chromatography-tandem mass spectrometry, capillary electrophoresis, differential scanning calorimetry, Fourier transform infrared spectroscopy, ultravioletvisible spectroscopy, near-infrared spectroscopy, nuclear magnetic resonance, potentiometry, and Xray diffraction. Results: Quantification of the drug by all the methods evaluated in the review was possible. There were 73 articles reviewed, of which 26 used HPLC for baclofen quantification; the least used was near infrared spectroscopy and potentiometry, both with one article identified. Conclusion: This review has shed light on a wide variety of analytical methods that can be used to quantify and identify baclofen. The knowledge provided by the use of these analytical methods makes this document an important tool for developing pharmaceutical formulations containing baclofen.
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A Review: Drug Excipient Iincompatiblity by Ftir Spectroscopy
Authors: Chander Singh, Komal Rao, Nikita Yadav, Nidhi Bansal, Yogesh Vashist, Shalini Kumari and Palak ChughFor the development of various formulations, it is necessary to check out the drug excipient incompatibility. Whether the drug is compatible with the excipient or not. Because the drug excipient interaction study provides stability data of the drug and shelf life of the drug. Fourier transform infrared spectroscopy is the best method to evaluate the drug excipient incompatibility study. The FTIR spectroscopy theory is based on the idea that molecules have a tendency to absorb particular light frequencies that are unique to the corresponding structure of the molecules. The energies depend on the atomic masses, the related vibronic coupling, and the geometry of the molecular surfaces. For instance, the molecule may be able to absorb the energy present in the incident light, which will cause it to rotate more quickly or vibrate more loudly. In this article, a list of various drugs with different excipients was discussed. This review emphasizes on various examples of drug interaction with a number of excipients on the basis of Fourier Transform infrared spectroscopy data which is based on last 10-12 year research paper, and the principle ,working, applications of infrared spectroscopy were also discussed.
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Review on Determination of Berberine in Biological and Pharmaceutical Matrices: An Analytical and Therapeutic Perspective
Berberine (BRB) is a natural alkaloid of the isoquinoline class, mostly isolated from the Berberis genus, which exhibits antibiotic, immunostimulant, antitumor, cardiovascular protection, endocrine regulator, antidepressant, neuroprotective, antioxidant, anti-inflammatory, and other pharmacological properties. The poor aqueous solubility of BRB is one roadblock in scaling up activities for the clinical drug. However, this can be overcome by its chemical modification into salt form. Extraction of this biologically beneficial component becomes one of the important aspects, and for that, several extraction techniques are available using a variety of solvents. Numerous analytical methods are reported for the quantification of extracted BRB as well as simultaneous estimation of BRB in the presence of other components. Among them, RP-HPLC, LC/MS, and UPLC/MS are the most frequently used methods. The effectiveness and preciseness of these advanced methods could be the reason for analysts’ preferred choice for analysis.
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Pitfalls and Opportunities in the Execution of Quality by Design in Analytical Sciences
Quality by Design (QbD) is a systematic approach integrated with quality risk management. It uses different design approaches followed by statistical analysis to yield a quality product. Now, the pharmaceutical industries are intrested in the application of QbD principles to analytical methods and term it as Analytical QbD (AQbD), which does not essentially mean less analytical testing; to a particular extent, it means the right analysis at the right time, supported by science and risk evaluation which ensures that the analytical method can be improved throughout its life cycle. However, for that, the analyst must have sound knowledge of Analytical Target Profile (ATP), method performance characteristics, risk assessment, choice of Design of Experiment (DoE), optimization of Method Operable Design Region (MODR). Some papers have cited the importance, regulatory flexibility, theoretical aspects, and statistical analysis of AQbD, but only a few discuss the core issue of gradual implementation of QbD in analytical sciences. For seamless transition, researchers need clarification on AQbD terminologies, acceptable methods, criteria to embrace critical quality attributes (CQAs), and standards to judge the adequacy of controls. This paper summarizes the challenges and solutions for the implementation of AQbD.
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Determination of Antithyroid Drug Propylthiouracil with Ru (III) in Pharmaceutical Formulations and its Characterization
Authors: Mukul Sharma and Afraim KotyBackground: Sulfur 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. Compared 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. Methods: An 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 μgmL-1 to 7.96 x102 μgmL-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%. Results: At 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. Conclusion: This 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.
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The Development and Validation of Simultaneous Quantitative Analysis Reversed-phase High-performance Liquid Chromatography for Sitagliptin Phosphate Monohydrate and Dapagliflozin Propanediol Monohydrate Fixed-dose Combination Dual-layered Tablet
Authors: So-Jin Kang and Joo-Eun KimBackground: Sitagliptin phosphate monohydrate-dapagliflozin propanediol hydrate fixeddose combination (FDC) dual-layered tablet is used for type 2 diabetes treatment. Simultaneous quantitative analysis can shorten the analysis time of sitagliptin phosphate monohydrate-dapagliflozin propanediol monohydrate FDC dual-layered tablets and increase their efficiency. Objective: This study aimed to develop the simultaneous quantitative analysis for sitagliptin phosphate monohydrate-dapagliflozin propanediol monohydrate FDC dual-layered tablet, a type 2 diabetes treatment. Methods: Simultaneous quantitative analysis using the rapid and selective reversed-phase highperformance liquid chromatography (RP-HPLC) method was developed and validated using method validation. RP-HPLC analysis was conducted using an ultraviolent absorption spectrophotometer and a Zorbax C18 column (4.6 x 150 mm, 5 μm). The flow rate and injection volume were set to 1.5 mL min-1 and 20 μL, respectively. The wavelength was set at 205 nm. Results: The retention times of sitagliptin phosphate monohydrate and dapagliflozin propanediol monohydrate were 2.28 mins and 10.65 mins, respectively. The relative standard deviations of the system suitability for validation of simultaneous quantitative analysis were 0.03% for sitagliptin phosphate monohydrate and dapagliflozin propanediol monohydrate. The chromatogram confirmed that there was no peak interference between the two main components and between the main component and the excipients. In addition, It revealed a favorable linearity with correlation coefficients of 0.9999 in the concentration range of 20-120% compared to the standard solution. Conclusion: The developed simultaneous quantitative analysis shortened the analysis time and high efficiency of the sitagliptin phosphate monohydrate-dapagliflozin propanediol monohydrate FDC bilayer tablet. The validity of the analytical method was verified through accuracy and precision, detection and quantitation limits, and solution stability tests. In addition, it was thought that it would be helpful in developing an analytical method by referring to the simultaneous quantitative analysis method for developing other FDC dual-layered tablets.
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Experimental and Theoretical Study of Biosurfactants Functionalized Gold Nanoparticles for Mixture Detection and Chiral Recognition of Tryptophan by UV-VIS Spectroscopy
Authors: Xiangzong Wu, Yanxia Li, Yiting Chen, Zhenli Qiu and Lu HuangBackground: Tryptophan (Trp) is an essential amino acid and plays important roles in biological processes. The detection of Trp is very important for its biological and chemical study. Moreover, Trp is a chiral compound; due to its importance in biological processes, researchers have been long committed to the chiral recognition and sensing of Trp enantiomers. Methods: Two biosurfactants, sodium cholate and sodium deoxycholate, were used for the preparation of functionalized gold nanoparticles (AuNPs) which were characterized by transmission electron microscope and potentiometer. UV-Vis spectra of functionalized gold nanoparticle solutions with different concentrations of Trp, tyrosine, phenylalanine, D-Trp, and L-Trp were analyzed. Then, the discrimination mechanism was further investigated, and the promotion mechanism of biosurfactants was studied by density functional theory (DFT). Results: Trp could induce the aggregation of unmodified AuNPs in 2 h, while phenylalanine and tyrosine could not. Adding biosurfactants promoted the aggregation process, and D- Trp rather than LTrp was found to be responsible for the aggregation. Therefore, there were interaction differences not only between Trp, phenylalanine, and tyrosine but also between Trp enantiomers. Conclusion: UV-vis spectroscopy could be applied for the direct detection of Trp in mixtures as well as the chiral recognition of Trp enantiomers. DFT calculations proved that the interactions of D-Trp with biosurfactants were the strongest, which contributes to the promotion of aggregation.
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Volumes & issues
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Volume 20 (2024)
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Volume 19 (2023)
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Volume 18 (2022)
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Volume 17 (2021)
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Volume 16 (2020)
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Volume 15 (2019)
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Volume 14 (2018)
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Volume 13 (2017)
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Volume 12 (2016)
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Volume 11 (2015)
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Volume 10 (2014)
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Volume 9 (2013)
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Volume 8 (2012)
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Volume 7 (2011)
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Volume 6 (2010)
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Volume 5 (2009)
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Volume 4 (2008)
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Volume 3 (2007)
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Volume 2 (2006)
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Volume 1 (2005)