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

Author(s): Harun Ergen, Muge Guleli, Cigdem Sener, Cem Caliskan*, Sercan Semiz, Mahmut Ozbek

Journal Name: Current Pharmaceutical Analysis

Volume 16 , Issue 7 , 2020

Become EABM
Become Reviewer
Call for Editor

Graphical Abstract:


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.

Keywords: Polyvinyl alcohol, RP-HPLC, RID detector, method development, validation, pharmaceutical.

[1]
Maribel, I. Baker; Steven , P. Walsh; Zvi, Schwartz.; Barbara , D. Boyan. A Review of Polyvinyl Alcohol and Its Uses in Cartilage and Orthopedic Applications. J Biomed Mater Res Part B, 2012, 100(5), 1451-7.
[2]
Muppalaneni, S.; Omidian, H. Polyvinyl alcohol in medicine and pharmacy: a perspective. J. Dev. Drugs, 2013, 2, 3.
[http://dx.doi.org/10.4172/2329-6631.1000112]
[3]
Aleksandrovich, I.F.; Lyubimova, L.N. Spectrophotometric determination of the polyvinyl alcohol content of sizing compositions. Fibre Chem., 1993, 24, 156-157.
[http://dx.doi.org/10.1007/BF00555038]
[4]
Finley, J.H. Spectrophotometric determination of the polyvinyl alcohol in paper coatings. Anal. Chem., 1961, 33, 1925-1927.
[http://dx.doi.org/10.1021/ac50154a044]
[5]
Joshi, D.P.; Lan-Chun-Fung, Y.L.; Pritchard, J.G. Determination of Poly(vinyl alcohol) via its complex with boric acid and iodine. Anal. Chim. Acta, 1979, 104, 153-160.
[http://dx.doi.org/10.1016/S0003-2670(01)83825-3]
[6]
Pritchard, J.G.; Akintola, D.A. Complexation of polyvinyl alcohol with iodine Analytical precision and mechanism. Talanta, 1972, 19(7), 877-888.
[http://dx.doi.org/10.1016/0039-9140(72)80256-X] [PMID: 18961134]
[7]
Morishima, Y.; Fujisawa, K.; Nozakura, S. Sequence length required for poly(vinyl acetate)-iodine and poly(vinyl alcohol)-iodine color reactions. Polym. J., 1978, 10(3), 281-285.
[http://dx.doi.org/10.1295/polymj.10.281]
[8]
Jones, S.A.; Brown, M.; Martin, G.P. Determination of polyvinyl alcohol using gel filtration liquid chromatography. Chromatographia, 2004, 59, 43-46.
[9]
Song, M.; Ma, H.M.; Huang, Y.X.; Liang, S.C. Determination of poly(vinyl alcohol) by adsorptive stripping voltammetry based on its Copper(II) Complex. Anal. Chim. Acta, 1997, 338, 103-108.
[http://dx.doi.org/10.1016/S0003-2670(96)00498-9]
[10]
Dunn, K.D. Determination of polyvinyl alcohol in a poly(DLlactide-co-glycolide) matrix by size exclusion chromatography using evaporative light scattering detection. J. Pharm. Biomed. Anal., 2001, 25(3-4), 539-543.
[http://dx.doi.org/10.1016/S0731-7085(00)00525-2] [PMID: 11377034]
[11]
Hashim, H.; El-Mekawey, F.; El-Kashef, H.; Ghazy, R. Determination of Scattering Parameters of Polyvinyl Alcohol by Static Laser Scattering. in: beni-suef university journal of basic and applied sciences; elsevier, 2014, 3, pp. 203-208.
[http://dx.doi.org/10.1016/j.bjbas.2014.10.005]
[12]
Guideline, I.C.H. validation of analytical procedures: text and methodology in proceedings of international conference on harmonization, topic q2 (r1),, geneva, switzerland 2005. November.,


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 16
ISSUE: 7
Year: 2020
Published on: 17 August, 2020
Page: [867 - 871]
Pages: 5
DOI: 10.2174/1573412915666190304152901
Price: $65

Article Metrics

PDF: 38
HTML: 3
PRC: 1