The
Malaysian Journal of Analytical Sciences Vol 16 No 3 (2012): 213 – 219
DEVELOPMENT AND VALIDATION OF A HPLC METHOD FOR THE
DETERMINATION OF LACIDIPINE IN PURE FORM AND IN PHARMACEUTICAL DOSAGE FORM
(Perkembangan dan Validasi Satu Kaedah KCPT Bagi Penentuan Lacidipine
Tulen
dan Dalam Dos
Farmaseutikal)
Mannur Vinodh*, Mastiholimath Vinayak, Kharya Rahul,
Patware Pankaj
Department of Quality Assurance,
KLE
University’s College of Pharmacy, Belgaum-
590 010, Karnataka,
India
*Corresponding author: vinodhmannur@yahoo.com
Abstract
A simple and
reliable high-performance liquid chromatography (HPLC) method was developed and
validated for Lacidipine in pure form and pharmaceutical dosage form. The
method was developed on Xbridge C-18 column (150 mm x 4.6 mm, 5 μm) with a mobile phase gradient system of ammonium acetate
and acetonitrile. The effluent was monitored by PDA detector at 240 nm.
Calibration curve was linear over the concentration range of 50 – 250
μg/ml. For Intra–day and inter–day precision % RSD values were found to be
0.83% and 0.41% respectively. Recovery of Lacidipine was found to be in the
range of 99.78-101.76%. The limits of detection (LOD) and quantification (LOQ)
were 1.0 and 7.3 μg/ml respectively. The developed RP-HPLC method was successfully
applied for the quantitative determination of lacidipine in pharmaceutical
dosage.
Keywords: Lacidipine, HPLC, Pharmaceutical dosage form,
Validation
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