Author/Authors :
Xie, Zengkun College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China , Wei, Lihua College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China , Yang, Qin College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China , Yang, Min College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China , Pan, Hongchun College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China , Liu, Hong College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China
Abstract :
The objective of the study was to develop a simple, specific and stability-indicating
HPLC method for the simultaneous determination of creatine phosphate sodium
(CPS) and its related substances in pharmaceutical formulation. Separation of creatine
phosphate sodium from its major process impurities and degradation products was
achieved on a Hypersil BDS C18 column (250 × 4.6 mm, 5 μm) with an aqueous mobile
phase containing 0.2% (w/v) tetrabutylammonium hydroxide (TAH) and 0.2% (w/v)
monopotassium phosphate adjusted to pH 6.6 with orthophosphoric acid at a flow rate
of 1.0 mL min-1. The analytes were detected at 210 nm. Different chromatographic
parameters were carefully optimized. The relative response factors for creatine, creatinine
and creatinine phosphate disodium salt relative to CPS were determined. The method has
been validated with respect to solution stability, system suitability, LOD, LOQ, linearity,
accuracy, precision, specificity and robustness. The validation criteria were met in all
cases. The developed method was successfully applied to determine the purity of CPS in
pharmaceutical formulation.
Keywords :
CPS , related substances , HPLC , stability-indicating method , method validation
