Development and validation of uplc method for the determination of olopatadine hydrochloride in polymeric nanoparticles

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GÜVEN U. M., Berkman M. S., Yazan Y.

Acta Pharmaceutica Sciencia, vol.57, no.1, pp.7-18, 2019 (Scopus) identifier

  • Publication Type: Article / Article
  • Volume: 57 Issue: 1
  • Publication Date: 2019
  • Doi Number: 10.23893/1307-2080.aps.05701
  • Journal Name: Acta Pharmaceutica Sciencia
  • Journal Indexes: Scopus
  • Page Numbers: pp.7-18
  • Keywords: Eudragit, Nanoparticles, Olopatadine hydrocloride, UPLC, Validation
  • Anadolu University Affiliated: Yes


© 2019, Istanbul Medipol University. All rights reserved.A new, simple, rapid, precise, accurate and specific stability indicating reverse phase UPLC method developed for the determination of encapsulated olopatadine hydrochloride (OLO) in the polymeric nanoparticle formulations. Studies were carried out on a 2.1x50 mm, 1.8 μm Zorbax Eclipse Plus C18 column with an optimized mobile phase of methanol, water and sodium acetate buffer solution (40:50:10, v/v/v) at a flow rate of 0.5 mL/min. OLO was detected and quantitated using a photodiode array detector at a wavelength of 246 nm and the column temperature was adjusted to 40 °C. The proposed method validation was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantitation and robustness according to the ICH harmonised tripartite guideline “validation of analytical procedures Q2(R1)”. Analytical curve was linear over the concentration range of 5-50 μg/mL. All the validation parameters were within the acceptance range. LOD and LOQ for OLO were 0.7652 and 2.3188 μg/mL, respectively. The developed method fulfilled the requirements for reliability and feasibility for the quantitative analysis of OLO in polymeric nanoparticles.