Development and validation of stability indicating RP-HPLC method for the determination of Epinastine Hydrochloride in Pharmaceutical dosage form

Authors

  • Aparajita Malakar Pharmacy Discipline, Life Science School, Khulna University, Khulna
  • Bishwajit Bokshi Pharmacy Discipline, Life Science School, Khulna University, Khulna

DOI:

https://doi.org/10.3329/icpj.v1i3.9662

Keywords:

Epinastine hydrochloride, validation, stability indicating method, HPLC, dosage form

Abstract

A simple, specific, accurate and stability-indicating high performance liquid chromatographic method was developed and validated for the determination of Epinastine Hydrochloride in pharmaceutical dosage form. The chromatographic conditions comprised of a reverse-phase, C18 column (150×4.6 mm), 5μm with a mobile phase consisting of a mixture of aqueous phase (3.8g of sodium pantanesulphonate monohydrate and 4.0g of potassium dihydrogen orthophosphate was dissolved in 1L of water and pH of solution was adjusted to 4.5 with o-phosphoric acid) and organic phase (acetonitrile and methanol was mixed in the ratio of 4:1 v/v) in the ratio of 60:40 v/v at a flow rate of 1.0ml/min. Detection was carried out at 220nm. The retention time of Epinastine Hydrochloride was found to be 3.5 min. The calibration curve was found linear between 2-200μg/ml. The percentage recoveries of Epinastine Hydrochloride were found to be in the range of 99.05-100.50%. The method was validated for accuracy, linearity, precision, detection limit, quantitation limit and robustness. The drug was subjected to acidic hydrolysis, basic hydrolysis, neutral hydrolysis, oxidation, photochemical and thermal degradation. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability indicating one.

Key Words: Epinastine hydrochloride; validation; stability indicating method; HPLC; dosage form.

DOI: http://dx.doi.org/10.3329/icpj.v1i3.9662

International Current Pharmaceutical Journal 2012, 1(3): 50-55

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How to Cite

Malakar, A., & Bokshi, B. (2012). Development and validation of stability indicating RP-HPLC method for the determination of Epinastine Hydrochloride in Pharmaceutical dosage form. International Current Pharmaceutical Journal, 1(3), 50–55. https://doi.org/10.3329/icpj.v1i3.9662

Issue

Vol. 1 No. 3 (2012)

Section

Original Articles

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