JOURNAL


Journal of Chemical Metrology
VOLUME & ISSUE
Available Online: April 29,2019
PAGES
p.1 - 6
DOI ADDRESS
http://doi.org/10.25135/jcm.23.19.03.1223
(DOI number will be activated after the manuscript has been available in an issue.)
STATISTICS
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AUTHORS
  • Evrim Kepekçi Tekkeli
  • Işıl Gazioğlu
  • Gizem Tırıs
  • Cem Önal
  • 1 - Bezmialem Vakif University
  • 2 -
  • 3 - Bezmialem Vakif University
  • 4 - Abdi İbrahim Pharmaceuticals
PDF OF ARTICLE

ABSTRACT


A simple, rapid, precise and accurate isocratic reversed phase HPLC method was developed and validated for the determination of lercanidipine hydrochloride in pharmaceutical tablets and spiked human breast milk. The chromatographic separation was achieved on C18 (250×4.6 mm×5µm) column using a mobile phase consisting of acetonitrile and phospate buffer (pH=4) (55:45, v/v) at a flow rate of 1.1 mL/min and UV detection at 237 nm. The linearity of the proposed method was investigated in the range of 1.0-40 μg/mL (r2=0.9990). The method was validated in terms of accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. The proposed method is found as suitable for routine quantification of lercanidipine in human breast milk.

KEYWORDS
  • Antihypertensive
  • Lercanidipine hydrochloride
  • HPLC-UV
  • Human breast milk
  • Method validation

SUPPORTING INFORMATION


Supporting Information
Download File 23-JCM-1903-1223-SI.pdf (427.96 KB)