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Information Journal Paper

Title

A stability-Indicating HPLC Method for Simultaneous Determination of Creatine Phosphate Sodium and its Related Substances in Pharmaceutical Formulation

Pages

  119-130

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 μ m) 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.

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    • Cite

    APA: Copy

    Xie, Zengkun, Wei, Lihua, Yang, Qin, YANG, MIN, Pan, Hongchun, & LIU, HONG. (2016). A stability-Indicating HPLC Method for Simultaneous Determination of Creatine Phosphate Sodium and its Related Substances in Pharmaceutical Formulation. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 15(1), 119-130. SID. https://sid.ir/paper/288525/en

    Vancouver: Copy

    Xie Zengkun, Wei Lihua, Yang Qin, YANG MIN, Pan Hongchun, LIU HONG. A stability-Indicating HPLC Method for Simultaneous Determination of Creatine Phosphate Sodium and its Related Substances in Pharmaceutical Formulation. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2016;15(1):119-130. Available from: https://sid.ir/paper/288525/en

    IEEE: Copy

    Zengkun Xie, Lihua Wei, Qin Yang, MIN YANG, Hongchun Pan, and HONG LIU, “A stability-Indicating HPLC Method for Simultaneous Determination of Creatine Phosphate Sodium and its Related Substances in Pharmaceutical Formulation,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 15, no. 1, pp. 119–130, 2016, [Online]. Available: https://sid.ir/paper/288525/en

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