(Pembangunan
dan Validasi Kaedah Analisis bagi Anggaran Serentak Artemether dan Luefantrine
dalam Keadaan Tulen dan Dos Farmaseutikal Mengunakan Kaedah KCPT-Fasa Terbalik)
Mannur
Vinodh*, Mastiholimath Vinayak, Patware Pankaj, Kharya Rahul and Mascarenhas
Renita
Department of Quality Assurance,
KLE
University’s College of Pharmacy, Belgaum-
590 010, Karnataka, India
*Corresponding
author: vinodhmannur@yahoo.com
Abstract
A
simple, rapid, precise and cost effective reversed phase-high performance
liquid chromatography (RP-HPLC) method was developed for the simultaneous
estimation of Artemether (AT) and Lumefantrine (LU) in pure drug and
pharmaceutical dosage forms. The separation was carried out using BDS Hypersil
C18 (150 × 4.6 mm i.d. 3 μm particle size) column, with mobile phase
comprising of 0.01M tetra butyl ammonium hydrogen sulphate and acetonitrile in
the ratio of 20 : 80 (v/v). The flow rate was 1.0ml/min and the detection was
carried out using UV-visible detector at 222 nm. The method was validated by
evaluation of different parameters such as accuracy, precision, linearity,
ruggedness, and robustness, limit of detection (LOD) and limit of
quantification (LOQ). The retention time were found to be 4.19 and 5.22 min for
AT and LU, respectively. Correlation coefficient (r2) of 0.999 for
both over concentration range of 3.2-19.2μg/ml and 16-96μg/ml for AT
and LU, respectively. Parameters like mobile phase ratio, wavelength, flow
rate, etc. were deliberately varied. It
was observed that there were no marked changes in chromatograms, which demonstrated
that the developed RP-HPLC method is robust. Intra and inter day precision
reproducibility study was carried out and it was checked by determining
precision on the same instrument, but by a different analyst. The percentage
recovery for AT and LU were ranged between 99.18-100.19 and 99.96-100.07,
respectively. The LOD for AT and LU were found to be 0.201 and 2.99 μg/ml
and the LOQ were 0.609 and 9.086 μg/ml respectively. Method was found to
be reproducible with relative standard deviation (RSD) for intra and inter day
precision less than 2%.
Keywords: Artemisinin-Based
Combination Therapy, Artemether, Lumefantrine, High Performance Liquid Chromatography (HPLC), Validation.
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