Spectrophotometric determination of the polyvinyl alcohol content of sizing compositions

Aleksandrovich, I. F.; Lyubimova, L. N.

doi:10.1007/bf00555038

Cited by 4 publications

(1 citation statement)

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“…Researches on quantitative analysis of PVA have been reported in the literature using ultraviolet spectrophotometric detection [9][10][11][12], infrared spectrophotometric detection [13], static laser scattering detection [14], gel filtration liquid chromatography with refractometry [15], adsorptive stripping voltammetry [16], SEC with evaporative light scattering detector (ELSD) [17] or RID [18], and reversed-phase high-performance liquid chromatography (RP-HPLC) with a chiral column [19]. Most of these methods are used in the textile or paper industry by detecting the absorbance of PVA-iodine-borate complex according to Beer-Lambert law.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Novel High-Performance Liquid Chromatography (HPLC)/Refractive Index Detector (RID) Method to Determine Residual Polyvinyl Alcohol (PVA) in Microspheres

Yin

Bin

Wang

et al. 2022

Journal of Chemistry

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Polyvinyl alcohol (PVA) is a commonly used emulsifier for the preparation of DL-lactide-co-glycolide (PLGA) and polylactic acid (PLA) microspheres with sustained-release profile. Although water-soluble PVA is normally considered to have low toxicity, monitoring residual level of PVAs is still necessary, especially for the chronic disease treatment medications containing PVA. In this study, a robust and validated method was developed for the determination of PVA using high-performance liquid chromatography (HPLC) and refractive index detector (RID). PVA in sustained-release microspheres containing PLGA, aripiprazole, mannitol, and PVA as active substances was analyzed by size exclusion chromatography (SEC) using acetonitrile/water/trifluoroacetic acid (TFA) (300 : 700 : 1; v/v/v) as mobile phase at a flow rate of 0.5 mL/min. The retention time was 11.2 min and PVA was well separated with other components with good linearity (r2 = 0.9997) in the range of 2.5∼75 μg/mL. The limit of detection (LOD) was 0.51 μg/mL and the limit of quantification (LOQ) was 2.53 μg/mL. The relative standard deviations of intra- and interday precision under different concentrations were not more than 2.1%, and the recoveries were all in the ranges of 95∼105%. The established method has been demonstrated to be accurate, precise, repeatable, specific, and robust and, therefore, suitable for routine analysis of PVA in not only pharmaceutical field but also food and textile industries.

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Section: Introductionmentioning

confidence: 99%

Development and Validation of a Novel High-Performance Liquid Chromatography (HPLC)/Refractive Index Detector (RID) Method to Determine Residual Polyvinyl Alcohol (PVA) in Microspheres

Yin

Bin

Wang

et al. 2022

Journal of Chemistry

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Simple spectrophotometric method for determination of polyvinylalcohol in different types of wastewater

Procházková

Rodríguez

Procházka

et al. 2013

International Journal of Environmental Analytical Chemistry

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Development And Validation of a LC-MS Compatible Method for Quantification of Degradation Impurities of Clofazimine Using UHPLC

Murty

Bhattacharjee

Krishnamurthy

et al. 2020

CPA

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Background: Clofazimine has antibacterial and leprostatic properties, which has its use in Multidrug Therapy (MDT) of leprosy. As per the FDA guidance for industry, each NDA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product. However, it was noticed that no stability indicating method is available in the literature for the estimation of degradation impurities of Clofazimine. Objective: Objective of the proposed work is to develop and validate a rapid, specific, linear, robust, accurate and sensitive Ultra High-Performance Liquid Chromatography (UHPLC) method with LC-MS compatible mobile phase for the quantification of degradation impurities of Clofazimine in a pharmaceutical dosage form (topical gel 0.5% w/w). Methods: Ultra High-Performance Liquid Chromatography equipped with PDA and Tunable UV (TUV) detector at a wavelength of 284 nm, stationary phase with a fused core particle technology, LC-MS compatible mobile phase was employed in this study. Gradient elution was employed for ensuring the selectivity of degradation impurities and clofazimine. This method was validated in accordance with ICH Q2 guidelines. This is the first reported Ultra High-Performance Liquid Chromatography method for estimation of degradation impurities of clofazimine. Results: The method showed good linearity over the range of 0.25 -1.5μg/ml of clofazimine. All the validation parameters were within the acceptance criteria. The product is found to degrade in the acid and peroxide degradation condition. The major degradant impurities are eluted at relative retention times of 0.35, 0.89 and 0.95. The developed method successfully separated the degradation products of clofazimine and able to quantitate accurately in its formulation. Conclusion: To date, there is no UHPLC method for determination of degradation impurities of clofazimine. in pharmaceutical dosage forms. Being a specific, linear, accurate and robust method, this would help in determining the chemical stability of drug product during the product development as well as in the shelf life of the drug product.

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Spectrophotometric determination of the polyvinyl alcohol content of sizing compositions

Cited by 4 publications

References 0 publications

Development and Validation of a Novel High-Performance Liquid Chromatography (HPLC)/Refractive Index Detector (RID) Method to Determine Residual Polyvinyl Alcohol (PVA) in Microspheres

Development and Validation of a Novel High-Performance Liquid Chromatography (HPLC)/Refractive Index Detector (RID) Method to Determine Residual Polyvinyl Alcohol (PVA) in Microspheres

Simple spectrophotometric method for determination of polyvinylalcohol in different types of wastewater

Development And Validation of a LC-MS Compatible Method for Quantification of Degradation Impurities of Clofazimine Using UHPLC

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