Current Pharmaceutical Analysis最新文献

{"title":"Synthesis of Polyaniline/BiPr Composite Oxide Nanowires with Enhanced Electrochemical Sensing Performance","authors":"Chenxu Feng, Zhangjie Ban, Jianfeng Huang, Yong Zhang, Zhengyu Cai, Lizhai Pei","doi":"10.2174/0115734129317923240808114505","DOIUrl":"https://doi.org/10.2174/0115734129317923240808114505","url":null,"abstract":"Background: Considerable interest has been devoted to electrochemical sensors for the detection of L-cysteine using BiPr-based oxide-modified electrodes due to high specific surface area and good electro-catalytic activity with several oxidation states. The combination of the BiPr composite oxide nanowires with polyaniline (PAn) can promote the electro-catalytic performance towards L-cysteine because PAn can facilitate the electro-catalytic process by enhancing the charge transfer. Methods: PAn/BiPr composite oxide nanowires were obtained via low temperature one-step hydrothermal route. The obtained composite oxide nanowires were analyzed by X-ray diffraction, electron microscopy, and electrochemical methods. Results: Characterization results indicate that amorphous PAn nanoparticles with a size of about 50 nm are homogeneously dispersed at the surface of the BiPr composite oxide nanowires. PAn/BiPr composite oxide nanowire-modified electrode shows an enhanced L-cysteine electro-catalytic activity. PAn promotes electro-catalytic activity of the BiPr composite oxide nanowires. A pair of quasi-reversible cyclic voltammetry (CV) peaks exist at +0.49 V, -0.19 V, respectively. PAn/BiPr composite oxide nanowire modified electrode possesses a linear response in L-cysteine concentration of 0.001-2 mM and detection limit of 0.095 μM, good repeatability, and stability. Conclusion: PAn/BiPr composite oxide nanowires act as effective electro-catalysts for L-cysteine oxidation resulting in the enhancement of the electro-catalytic activity relative to BiPr composite oxide nanowires.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142223944","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":"Green Analysis by Eco-Scale Assessment for Quality Control of Azithromycin Tablets","authors":"Aline Sinzervinch, Ana Carolina Kogawa","doi":"10.2174/0115734129306660240808104954","DOIUrl":"https://doi.org/10.2174/0115734129306660240808104954","url":null,"abstract":"Background: Azithromycin (AZT), an antimicrobial, despite having a monograph in official compendiums and some methods available in the literature, there is still a demand for eco-efficient methods, which include green analytical chemistry. Objective: This study aimed to develop and validate a green spectrophotometric method for quantifying AZT tablets. Method: Purified water and ethanol (90:10, v/v) and sulfuric acid 20% as a diluent and reagent, respectively, quartz cubette and 482 nm were used. The Eco-Scale Assessment (ESA) tool was used to evaluate the greenness of the proposed analytical method. Results: The proposed method was linear (20-70 μg mL-1 with a correlation coefficient of 0.9984), precise (RSD < 5%), selective by sample adjuvants, exact (100.46%), and robust against changes in acid proportion and wavelength. The ESA calculation was 85 points. Conclusion: The proposed method can be classified as an excellent green alternative to quantify AZT in tablets, in accordance with ESA.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142181903","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 Diphenidol in Mouse Plasma and Application to a Pharmacokinetic Study Using Uplc-Ms/Ms","authors":"Rong Lin, Xicheng Dong, Wenwen Huang, Xianqin Wang, Jianshe Ma","doi":"10.2174/0115734129329904240731105655","DOIUrl":"https://doi.org/10.2174/0115734129329904240731105655","url":null,"abstract":"Objective: Difenidol is widely used in clinical practice due to its good anti-dizziness effect and low side effect rate. This aim was to develop an ultra-high performance liquid chromatography- tandem mass spectrometry (UPLC-MS/MS) method for the selective and straightforward measurement of diphenidol in mouse plasma. Methods: A total of eighteen mice were divided into three groups: six for intravenous administration at a dose of 0.2 mg/kg, six for oral administration at a dose of 0.4 mg/kg, and another six for oral administration at a dose of 1.6 mg/kg. The analytes were extracted using acetonitrile-mediated protein precipitation following the addition of the internal standard (IS), midazolam. On an Acquity HSS T3 column (50 mm × 2.1 mm, 1.8 μm). The quantification process involved the use of multiple reactions monitoring (MRM) mode, with target fragment ions m/z 310.2→128.9 for diphenidol and m/z 326.2→291.4 for IS. Results: For diphenidol, calibration curves showed a linear distribution between 0.2 and 50 ng/mL. The accuracy of the method was between 94.6% and 110.4%, and the mean recovery of diphenidol in mouse plasma was over 76.5%. The intra-day and inter-day precision RSDs were both limited to 14%. The bioavailability of diphenidol in mice was determined to be 19.9% and 23.56% for the oral dose of 0.4 mg/kg and 1.6 mg/kg, respectively. Conclusion: The UPLC-MS/MS was successfully applied to study the pharmacokinetics of diphenidol in mice, to which it was administered orally and intravenously.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142181904","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 Mesalamine in Bulk and Suppository Dosage Forms through the Development and Validation of Stability- indicating RPHPLC Method","authors":"Nilima Anil Chaudhari, Nisharani Sudhakar Ranpise","doi":"10.2174/0115734129308140240715052552","DOIUrl":"https://doi.org/10.2174/0115734129308140240715052552","url":null,"abstract":"Background: In the current study, a simple and cost-effective stability-indicating RP-HPLC method was developed and validated to estimate the mesalamine from both bulk and pharmaceutical dosage forms. Methods: An isocratic HPLC method using a reverse phase HiQSilC18 column (250 x 4.6 mm, 5μm) and a mobile phase methanol: ammonium acetate buffer (90:10 v/v) were employed as the mobile phase with a flow rate of 1 mL/min at 25°C. Detection was carried out at 305 nm, and the injection volume was 20μl. The developed method was validated as per ICH Q2 guidelines. Mesalamine has been subjected to various stress testing conditions, such as hydrolysis of acid and base, thermal degradation, oxidation, and photolysis. Also, methods have been validated with regard to linearity, accuracy, precision, and robustness. Results: The RT of mesalamine was determined to be 3.550 min ± 0.024 minutes, providing a reliable marker for its identification. The method was found to be linear between 5-30 μg/mL concentration with (R²) of 0.994. This demonstrated the method's ability to measure varying concentrations of mesalamine accurately. Additionally, the percentage recovery of mesalamine was approximately 100%, confirming the accuracy of the developed method. The parameters for system suitability have also been found to be within acceptable limits. Force degradation studies reinforced the method's selectivity and sensitivity in detecting mesalamine under various degradation scenarios. Notably, mesalamine significantly degraded in an acidic environment. Conclusion: In conclusion, our proposed RP-HPLC method provides a sensitive, accurate, and precise means of analyzing mesalamine in both bulk and pharmaceutical dosage forms. result: The RT of mesalamine was determined to be 3.560 min ± 0.034 minutes, providing a reliable marker for its identification. The method was found linear between 5-30 μg/mL concentration with (R²) of 0.987. This demonstrates the method's ability to accurately measure varying concentrations of mesalamine. Additionally, the percentage recovery of mesalamine was approximately 100%, confirming the accuracy of the developed method. The parameters for system suitability have also been found to be within acceptable limits. Force degradation studies reinforced the method's selectivity and sensitivity in detecting mesalamine under various degradation scenarios. Notably, mesalamine significantly degraded in an acidic environment.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141942459","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":"A Comprehensive Review of Analytical Methods Developed for Selective Serotonin Reuptake Inhibitors (SSRIs)","authors":"Ansari Mahzabin Safdarali, Lalit Lata Jha, L. D. Patel","doi":"10.2174/0115734129298467240718104217","DOIUrl":"https://doi.org/10.2174/0115734129298467240718104217","url":null,"abstract":": Selective Serotonin Reuptake Inhibitors (SSRIs) are a key development in psychological pharmacology and treatment. It has been demonstrated that serotonin (5-HT) has a pharmacological role in a variety of anxiety- and mood-related conditions. Fluvoxamine, citalopram, escitalopram, paroxetine, sertraline, and fluoxetine are the six primary SSRIs now available in the United States for the treatment of depression and anxiety or mood-related disorders. Despite having a different chemical structure, these compounds function in an analogous fashion. The main mechanism by which SSRIs work is by preventing serotonin from being reabsorbed presynaptically at the serotonin transporter, which raises serotonin at the postsynaptic membrane, which is found in the serotonergic synapse. In order to ensure the effectiveness, safety, and quality control of SSRIs in pharmaceutical formulations, it is crucial to quantify them precisely. The present article provides an overview of the main analytical techniques developed to evaluate SSRIs in different matrices. It covers both conventional and hyphenated approaches and concentrates on the analytical methodologies developed to quantify SSRIs. It offers a general overview of the methods that have been developed and standardized for the evaluation of SSRIs in drug formulations and various matrices. It focuses on the major components of SSRI analysis, such as the solvents used for analysis, chromatographic column selections, detection wavelength, and validation parameters. It also discusses various validation parameters, such as accuracy, precision, retention duration, maximum absorbance wavelength (λmax), range, limit of detection (LOD), and limit of quantitation (LOQ).","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141942542","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 Chlorogenic Acid in Solid-Lipid Nanoparticles: Validation by UV-spectroscopy","authors":"Tarapati Rana, Anju Goyal, Tapan Behl","doi":"10.2174/0115734129303063240711073707","DOIUrl":"https://doi.org/10.2174/0115734129303063240711073707","url":null,"abstract":"Objective: The objective of the research was the development and validation of a simple, sensitive, accurate, robust, and precise UV-spectroscopic method for the quantitative determination of chlorogenic acid loaded in solid-lipid nanoparticles as per the guidelines of the International Conference on Harmonization. Methods: The solid-lipid nanoparticles of chlorogenic acid were prepared using the hot melt emulsification method and the high-speed homogenizer method. Glyceryl monostearate was used as a solid lipid, and Tween 80 was used as a surfactant for the preparation of chlorogenic acid-loaded solid lipid nanoparticles. The method was validated in terms of linearity, accuracy, precision, robustness, ruggedness, limit of detection, and limit of quantification. Results: The chlorogenic acid exhibited absorption maxima at the wavelength of 330 nm. The regression equation from the calibration curve was y=0.006x + 0.0193 with a correlation coefficient of 0.9989. The percentage recovery was found to be 99.92, 99.80, and 99.86, respectively (within the acceptable limit of 98-102%), which validated the accuracy of the method. Furthermore, the method exhibited precision, robustness, and ruggedness, as illustrated by a relative standard deviation (RSD) of less than 2%. The limit of detection and limit of quantification were found to be 6.97 and 21.13 μg/ml, respectively. Conclusion: It was concluded that the proposed spectrophotometer analytical method for the determination of Chlorogenic acid was found reliable, accurate, consistent, precise, accurate, and robust. Therefore, the proposed analytical technique could be an integral part of further evaluation and characterization of Chlorogenic acid-solid lipid nanoparticles.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141778712","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":"Assessment of Analytical Techniques for Precise Quantification of Four Antiviral Drugs in Pharmaceutical Research and Development: A Comprehensive Review","authors":"Akhil Gupta, Shilpi Pathak","doi":"10.2174/0115734129302705240703052227","DOIUrl":"https://doi.org/10.2174/0115734129302705240703052227","url":null,"abstract":": Precise measurement of drug concentration in pharmaceutical research is critical, especially for anti-viral drugs like boceprevir, elvitegravir, indinavir, and saquinavir that combat viral infections. It is well-known that analytical techniques play an imperative role in identifying and characterizing active pharmaceutical ingredients in biological samples and drug formulations. Moreover, precise drug assessment directly influences safety, stability, and efficacy while providing in-depth insight into drug pharmacokinetics. Other than this, analytical techniques also aid in identifying impurities, deteriorated products, and potential pollutants. Thus, reliable analytical methods have become crucial for addressing challenges imposed by complex drug formulations. The most commonly used analytical technique is UV spectrophotometry, which does not have the high sensitivity to detect complex drug formulations. In contrast, Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) merges two analytical techniques, chromatography and mass spectrometry, to accurately quantify biological samples. Furthermore, Ultra-Performance Liquid Chromatography (UPLC) provides enhanced resolution, faster analysis in short duration, and low solvent consumption in contrast to HPLC. This comprehensive review aims to critically assess each analytical approach's accuracy, applicability, selectivity, and limitation to provide valuable insights for researchers and analysts. Understanding the weaknesses and strengths of these analytical techniques will enable the researchers to select the suitable analytical method based on their needs and requirements for quality assessment, precise drug quantification, and optimal therapeutic efficiency. Eventually, this review intends to advance pharmaceutical research and development, specifically for anti-viral drugs, by ensuring the effective and secure administration of therapies.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141722123","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":"Characterization of Carbamide Peroxide: Stability Studies, and Degradation Kinetics under Isothermal Conditions for Industrial Application","authors":"Fabiana Vieira Lima Solino Pessoa, Rafael Nicolay Pereira, Cassiana Mendes, Marcos Antonio Segatto Silva","doi":"10.2174/0115734129305540240702114124","DOIUrl":"https://doi.org/10.2174/0115734129305540240702114124","url":null,"abstract":"Background: Carbamide peroxide (CP) is a hydrogen peroxide derivative bonded with urea. It is asolid substitute for liquid hydrogen peroxide in the chemical, cosmetics, and pharmaceutical industries, mainly as a disinfectant and bleaching application. However, it has an unstable nature, and there are scant studies on CP thermal analysis. Objective: This study focuses on CP thermal analysis and degradation behavior Methods: CP was characterized by differential scanning calorimetry, thermogravimetric analysis, Fourier-transformed infrared, diffraction by X-ray, as well as, thermal and photodegradation was determined by ultraviolet spectrophotometer. Results: CP was characterized with a sharp endothermic event (88.50 oC; ΔH= -643.20 J.g-1), and a thermal decomposition behavior in a four-steps process. The pattern diffraction presented sharp peaks at 2θ: 15.2, 25.1 and 26.0o . The Arrhenius plot obtained by isothermal thermogravimetric analysis showed a linear relation with temperature in two steps. The first step the activation energy values was Ea = 45.73 J.mol-1.K-1. The thermal degradation recovery was 3.29% after 5 days, and 11.31% against 97.4% under the dark control to photostability. Conclusion: The study contributed to characterizing the CP and the results suggest that degradation depends on the surface transition state and the ternary formed system (CP-urea-water) and that the temperature influenced this system. The data were obtained through quick and easy techniques, which use wispy raw material and presented a significant result that can be used by the entire industry in the development of new formulations.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141608269","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":"Applicability of Salting-Out Liquid-Liquid Extraction for New Fluorimetric Quantification of Omadacycline in Pharmaceutical Formulations and\u0000Biological Samples","authors":"Eman Alzahrani, Mohamed A. Abdel-Lateef, Baher I. Salman","doi":"10.2174/0115734129322131240708103234","DOIUrl":"https://doi.org/10.2174/0115734129322131240708103234","url":null,"abstract":"\u0000\u0000A detectable innovative fluorimetric method was used to determine OMC in\u0000human plasma matrices, pharmaceutical tablets, and vials with high recovery rates and without biological\u0000interference.\u0000\u0000\u0000\u0000The fluorimetric technique was used based on the interaction between 4-chloro7-nitrobenzofurazan\u0000(NBD-Cl) with a (2-ry amine group) in OMC with pH 8.0, which generates a fluorescent\u0000compound measured at 530 nm (exci 470 nm) following a 10-minute heating step at 80 oC.\u0000The plasma and milk samples were treated with ammonium sulfate as a salting-out procedure.\u0000\u0000\u0000\u0000Omadacycline (OMC) was successfully determined in pharmaceutical, plasma, and milk\u0000samples with a linear range from 60.0 to 700.0 ng mL-1, with the lower limit of detection (LOD\u00005.18 ng mL-1) and limit of quantitation (LOQ 15.72 ng mL-1).\u0000\u0000\u0000\u0000This simple, reliable, and detectable fluorimetric method was successfully developed\u0000to determine omadacycline in pharmaceutical tablets, plasma samples, and milk with high recovery\u0000rates.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.7,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141654910","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":"Robust U-HPLC Method Development of Desonide and its Application to In Vitro Release Testing (IVRT) of Topical Cream Products","authors":"Seelam Jayadev, Ismail Y","doi":"10.2174/0115734129298659240606103013","DOIUrl":"https://doi.org/10.2174/0115734129298659240606103013","url":null,"abstract":"Background: The study focuses on establishing In Vitro Release Testing (IVRT) parameters for Desonide cream, following the guidelines of the Topical Classification System (TCS), to assess the bioequivalence between the Reference Listed Drug (RLD) and test. Aim: This study aimed to develop a reliable IVRT method using Franz diffusion cells. An environmentally friendly U-HPLC method was created to analyze Desonide in the samples. objective: This includes assessing Linearity, robustness, precision, sensitivity, reproducibility, selectivity, specificity, and recovery. In the context of In-vitro Release Testing (IVRT), the concept of accuracy becomes irrelevant because there isn't a definitive "actual" release rate. This is due to the variability in API release rates for a specific semisolid formulation under different test conditions Objective: To evaluate the drug release in Desonide products in accordance with SUPAC guidance, quantify the drug concentration using an analytical method, as per bioanalytical method validation guidelines, and ensure that the results meet the acceptance criteria. Linearity was established from 0.50μg/mL to 40μg/mL with acceptable regression values. Precision was confirmed three times, with an average % RSD of below 15% for 3 sets of 6QC level sample preparations. Stability tests demonstrated Desonide stability in receptor fluid (LLOQ and ULOQ) for 72 hours at 2-8°C and 25°C. Autosampler stability at LQC and HQC levels was proven at 25°C for 72 hours. Additionally, the stock solution remained stable at both 25°C and 2-8°C for 72 hours. Methods: The study involved evaluating the dosing regimen, release medium, and membrane while optimizing the U-HPLC method based on three variables including column temperature, mobile phase composition, and flow rate. After experimentation, it was determined that Nylon membrane and 0.9% NaCl: Methanol release media (70:30 v/v) with 1000 mg dose were used to maximize the release profile of desonide. Results: The created explanatory strategy is precise, delicate, and exact for measuring Desonide, with satisfactory Limits of Location LOD and Lower Limits of Measurement LLOQ measured at 0.15 and 0.50 ng /mL, respectively. The Regression coefficient r2 was identified to be 0.9996. The degree of Desonide measurement lessening was considered palatable, basically since the recuperation was underneath 30.00, additionally due to the favourable linear relationship watched within the Desonide discharge rates amid the IVRT study. Conclusion: All three generic products analyzed were found to be equivalent to the RLD, meeting for \"sameness\" outlined in the FDA's SUPAC-SS guidance. A novel U-HPLC method was developed for Desonide, covering the range from 0.5 to 40 μg/ml, with intra and inter-day variability below 2% RSD. Additional characterizations were established, and the stability of Desonide was successfully determined.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141588433","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}