JOURNAL 2830


Journal of Chemical Metrology
VOLUME & ISSUE
Year: 2023 Issue: 2 July-December
PAGES
p.128 - 138
STATISTICS
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AUTHORS
  • Divyakumari Kiransinh Solanki
  • Sagarkumar P. Patel
  • Sagarkumar Patel
  • Jasmina Surati
  • Ashok Akabari
  • Dipansu Sahu
  • Ketan Shah
PDF OF ARTICLE

GRAPHICAL ABSTRACT


ABSTRACT


Simple, accurate, precise, and sensitive reverse-phase high-performance liquid chromatographic (HPLC) method was developed for the simultaneous measurement of ARI and ESC in pharmaceutical products by using a C18 column with dimensions of 250 mm x 4.6 mm and a particle size of 5 μm. The mobile phase consisted of a mixture of acetonitrile, methanol, and water in the ratio of 80:05:15 v/v/v. Orthophosphoric acid was added to adjust the pH to 7.00 ± 0.1. The detection wavelength used for measuring the absorbance of the components was 246 nm, and the Mobile Phase flow rate was set at 1.0 mL/min. The retention times of ARI and ESC were 5.63 and 3.65 minutes, respectively. The ARI and ESC correlation coefficients (R2-values) were observed at 0.9995 and 0.9997, respectively, demonstrating a robust linear relationship between the analyte concentration and the observed absorbance. The linearity range for ARI was 20 to 120 μg/mL, while ESC was 60 to 360 μg/mL. The recovery percentages for ARI and ESC ranged from 99.43% to 100.65% and 99.58% to 100.15%, respectively. Additionally, all parameter uncertainty levels were below 2. The method was validated following ICH guideline Q2 (R1). The analytical method validated will be successfully applied to the pharmaceutical dosage form.

KEYWORDS
  • Aripiparzaol
  • Escitalopram
  • HPLC
  • method validation

SUPPORTING INFORMATION


Supporting Information
Download File A1-92-JCM-2307-2830-SI.pdf (419.92 KB)