TITLE:
Development and Application of a Validated HPLC Method for the Determination of Clindamycin Palmitate Hydrochloride in Marketed Drug Products: An Optimization of the Current USP Methodology for Assay
AUTHORS:
Geoffrey K. Wu, Abhay Gupta, Mansoor A. Khan, Patrick J. Faustino
KEYWORDS:
Clindamycin Palmitate Hydrochloride (CPH); HPLC; Method Validation; Pediatric Dosage Form
JOURNAL NAME:
Journal of Analytical Sciences, Methods and Instrumentation,
Vol.3 No.4,
October
22,
2013
ABSTRACT:
A
simple efficient isocratic reversed-phase HPLC method was developed and
validated for the determination of clindamycin palmitate hydrochloride (CPH)
and its commercially available oral solution products. Separation was achieved
on a Phenomenex Zorbax (Luna) cyano column (150 × 4.6 mm, 5 μm) with a Phenomenex cyano guard cartridge
(4 × 3.0 mm) on
Agilent 1050 series HPLC system. CPH and its resolution standard lincomycin
were eluted isocratically at a flow rate of 1 mL/min with a simplified mobile
phase (potassium phosphate buffer (5 mM, pH 3.0)—acetonitrile—tetrahydrofuran
(20:75:5, v/v/v)) and detected at 210 nm. The column was maintained at 25?C.
The method was validated according to USP category I requirements. Robustness
and forced degradation studies were also conducted. CPH marketed drug products
were obtained from a drug distributor and assayed for potency using the validated
method. Validation acceptance criteria were met in all cases. The analytical
range for CPH was 15 - 500 μg/mL and the linearity was r2 > 0.999 over three days. The method was determined to be specific and
robust. Both accuracy (92.0% - 103.8%) and precision (0.67% - 1.52%) were established across the analytical range for low, intermediate
and high QC concentrations. Method applicability was demonstrated by analyzing
two marketed products of CPH, in which results showed potency >98%. The
method was determined to be an enhancement over the current USP methodology for
assay as a result of increased efficiency, reduced organic solvents and the
elimination of matrix modifiers. This method was successfully applied for the
quality assessment of: 1) currently marketed drug products and 2) will in
future assess the product quality of novel dosage forms of CPH for pediatric
use.