Development and Validation of a Novel Reversed Phase High Performance Liquid Chromatography with Refractive Index Detector Method for Assay of Polyvinyl Alcohol in an Ophthalmic Solution

Abstract

Introduction: Polyvinyl alcohol (PVA), a polymer, is in demand due to its usage in different applications such as pharmaceutical, biomedical and textile, paper, food industries. Methods: A new sensitive reversed phased high-pressure liquid chromatography (RP-HPLC) method with refractive index detector (RID) was developed for determination of PVA in an ophthalmic solution containing dexpanthenol and PVA as active substances and it was validated according to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline. Results: Chromatographic separation was achieved on a Chiral-AGP (150 mm × 4.0 mm, 5 μm) column kept at 30°C with an isocratic flow at a flow rate of 1.0 ml/min. The detector temperature was 30°C, the retention time of PVA was around 1.0 min and the total run time was 5 minutes. Conclusion: The proposed method showed linearity, accuracy, precision, specificity, robustness, solution stability, and system suitability results within the acceptance criteria.

Realizing Ultrapurified Poly(vinyl alcohol) with High Insulation and Transparency by Ecofriendly Supercritical Assisted Elimination of Sodium-Associated Impurities

“…Various methods involving chromatography, heating evaporation, and solvent dissolution have been practiced to remove impurities in polymeric materials. The latter two means constitute two main approaches to remove small molecular impurities.…”

“…20,21 Thereby, an essential prerequisite for improving the electro-optic properties of PVA and, thus, expanding its potential applications, is to eliminate sodium-associated residuals. Various methods involving chromatography, 22 heating evaporation, 23 and solvent dissolution 24 have been practiced to remove impurities in polymeric materials. The latter two means constitute two main approaches to remove small molecular impurities.…”

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

“…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.…”

“…Almost all of these methods are not suitable for pharmaceutical field. Although there are sparse literature works [17][18][19] that aimed at developing a method for pharmaceutical use, these methods suffer from the need for pricey equipment, bad resolution power, band broadening, low sensitivity, and limited application fields. e SEC method in reference [17] has obvious advantages in terms of high sensitivity with LOD of 4∼20 μg/mL and excellent accuracy with recoveries of 96.03∼101.22%.…”

“…e RP-HPLC method using a Chiral-AGP (150 mm × 4.0 mm, 5 μm) column in literature [19] is rapid and reliable and has low cost. Unfortunately, the sensitivity including LOD and LOQ has not been given exactly in the paper.…”