Development and validation of RP-UPLC method for the determination of betamethasone dipropionate impurities in topical formulations using multivariate central composite design approach.

2021 ◽  
Author(s):  
Siva Krishna Muchakayala ◽  
Kommera Pavithra ◽  
Naresh Kumar Katari ◽  
Vishnu Murthy Marisetti ◽  
THIRUPATHI DONGALA ◽  
...  
Keyword(s):  
Central Composite Design ◽  
Method Development ◽  
Betamethasone Dipropionate ◽  
Design Approach ◽  
Topical Formulations ◽  
Development And Validation ◽  
Central Composite ◽  
Determination Of Impurities

Current study portrays a specific, accurate, simple and rapid UPLC method development for the determination of impurities present in two different topical formulations (Cream and Ointment) of betamethasone dipropionate. The...

scholarly journals Carbon dots as absorbance promoter probes for detection of Cu(ii) ions in aqueous solution: central composite design approach

2018 ◽  
Vol 17 (2) ◽  
pp. 245-255 ◽  
Author(s):  
S. A. R. Shahamirifard ◽  
M. Ghaedi ◽  
M. Montazerozohori ◽  
A. Masoudiasl
Keyword(s):  
Aqueous Solution ◽  
Central Composite Design ◽  
Carbon Dots ◽  
Design Approach ◽  
Complexing Agent ◽  
Vis Spectroscopy ◽  
First Time ◽  
Central Composite ◽  
Determination Of Copper

In this work, the use of carbon dots (CDs) as a complexing agent and sensitizer in a polymeric matrix for determination of copper(ii) by UV-vis spectroscopy is reported for the first time.

scholarly journals Optimization of a spectrofluorimetric method based on a central composite design for the determination of potassium losartan in pharmaceutical products

2014 ◽  
Vol 50 (3) ◽  
pp. 611-619 ◽  
Author(s):  
Fatma Demirkaya-Miloglu ◽  
Mehmet Emrah Yaman ◽  
Yucel Kadioglu
Keyword(s):  
Central Composite Design ◽  
Reference Method ◽  
Pharmaceutical Products ◽  
Critical Parameters ◽  
Fluorescent Intensity ◽  
Spectrofluorimetric Method ◽  
Acid Molarity ◽  
Development And Validation ◽  
Central Composite

Here, a spectrofluorimetric method for the determination of potassium losartan (PL) in pharmaceutical products is described. The effects of critical parameters, pH, acid molarity, and temperature, on the fluorescence intensity of PL were analyzed, and these parameters were optimized using a central composite design (CCD). The highest fluorescent intensity at excitation (λex) and emission (λem) wavelengths of 248 nm and 410 nm, respectively, was achieved using 0.01 M sulfurous acid (pH 2) at 21.6 °C. Under optimum conditions, the method was linear from 0.025-0.5 µg/mL, with a reasonably high correlation coefficient (0.9993). Furthermore, the method was very sensitive (LOQ, 0.006), accurate (RE, ≤7.06), and precise (%RSD, ≤6.51). After development and validation of the method, samples containing PL were analyzed with this method, and the obtained data were statistically compared with those obtained with a previously published reference method using a two one-sided equivalence test (TOST). According to the data, the results from the proposed and reference assays were equivalent.

Bioanalytical Method Development and Validation for the Determination of Vasopressin Receptor Antagonist Conivaptan in Mouse Plasma at NanoLevel and its Pharmacokinetic Application

2019 ◽  
Vol 15 (5) ◽  
pp. 591-598 ◽  
Author(s):  
Haitham Alrabiah ◽  
Ahmed Bakheit ◽  
Sabray Attia ◽  
Gamal A.E. Mostafa
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Vasopressin Receptor ◽  
Mouse Plasma ◽  
Precipitation Procedure ◽  
Validation Parameters ◽  
The Us ◽  
Method Development And Validation ◽  
Development And Validation

Background: Conivaptan inhibits two of vasopressin receptor (vasopressin receptor V1a and V2). Conivaptan is used for the treatment of hyponatremia, and in some instances, for the treatment of the heart failure. Methods: The present study aimed to develop a simple, sensitive, and accurate HPLC with ultraviolet detection for the assay of conivaptan (CON) in mouse plasma using bisoprolol as internal standard (IS). A precipitation procedure was used to extract CON and the IS from the mouse plasma. CON was chromatographically separated using a C18 analytical column at 25°C. The separation was carried out using a mixture of phosphate buffer (50 mM): acetonitrile (60: 40, v/v, pH 4.5) with a flow rate of 1.0 mL/min and detection was performed at 240 nm. Results: The assay was validated according to the US Food and Drug (FDA) guidelines. The method demonstrated linearity over a concentration range of 150 - 2000 ng/mL (correlation coefficient: r 2 = 0.9985). The mean recovery of CON from the mouse plasma was 101.13%. All validation parameters for CON were within the acceptable range. Conclusion: The investigated method has been shown to be suitable for estimating the CON in plasma samples, and this method is sensitive and highly selective, allowing the estimation of its concentrations up to the nano-scale. The suggested method was successfully used in a pharmacokinetic study of CON in mouse plasma.

scholarly journals A novel LC-MS method development and validation for the determination of phenyl vinyl sulfone in eletriptan hydrobromide

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Indhu Priya Mabbu ◽  
G. Sumathi ◽  
N. Devanna
Keyword(s):  
Method Development ◽  
Limit Of Detection ◽  
Vinyl Sulfone ◽  
Limit Of Quantification ◽  
Relative Standard ◽  
Pressure Chemical Ionization ◽  
Pressure Chemical ◽  
Development And Validation ◽  
Phenyl Vinyl

Abstract Background The aim of the present method is to develop and validate a specific, sensitive, precise, and accurate liquid chromatography-mass spectrometry (LC-MS) method for the estimation of the phenyl vinyl sulfone in the eletriptan hydrobromide. The effective separation of the phenyl vinyl sulfone was achieved by the Symmetry C18 (50 × 4.6 mm, 3.5 μm) column and a mobile phase composition of 0.1%v/v ammonia buffer to methanol (5:95 v/v), using 0.45 ml/min flow rate and 20 μl of injection volume, with methanol used as diluent. The phenyl vinyl sulfone was monitored on atomic pressure chemical ionization mode mass spectrometer with positive polarity mode. Results The retention time of phenyl vinyl sulfone was found at 2.13 min. The limit of detection (LOD) and limit of quantification (LOQ) were observed at 1.43 ppm and 4.77 ppm concentration respectively; the linear range was found in the concentration ranges from 4.77 to 27.00 ppm with regression coefficient of 0.9990 and accuracy in the range of 97.50–102.10%. The percentage relative standard deviation (% RSD) for six replicates said to be injections were less than 10%. Conclusion The proposed method was validated successfully as per ICH guidelines. Hence, this is employed for the determination of phenyl vinyl sulfone in the eletriptan hydrobromide.

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