A stability-Indicating HPLC Method for Simultaneous Determination of Creatine Phosphate Sodium and its Related Substances in Pharmaceutical Formulation.
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.
College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China. ; Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control, Chongqing, China.
Zengkun
Z
Xie
College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China. ; Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control, Chongqing, China.
Lihua
L
Wei
College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China.
Qin
Q
Yang
College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China. ; Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control, Chongqing, China.
Min
M
Yang
College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China. ; Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control, Chongqing, China.
Hongchun
H
Pan
College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China. ; Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control, Chongqing, China.
Hong
H
Liu
CPS; HPLC; method validation; related substances; stability-indicating method