Abstract:
The content of calcium carbonate in
Xiaokening tablets has been determined by the powder
X-ray diffraction (PXRD) method. The full spectrum fitting internal standard quantification method was used, with zinc oxide as the internal standard, using Cu K
α rays, the voltage was 40 kV, and the current was 45 mA, the scan type was Coupled Two Theta/Theta, the scan mode was Continuous PSD fast, and the diffraction angle (2
θ) scanning range was 8 °~40 °, with a step size of 0.02 °. The PXRD pattern was obtained by scanning, and the percentage content of calcium carbonate was obtained by the internal standard quantitative analysis with a Total Pattern Solution (TOPAS) software. The methodological validation results showed that the mean spiked recovery was 98.9% relative standard deviation (RSD) was 1.0%,
n=6. The mock samples were validated using three levels of low, middle and high, and the average recovery was 96.9% (RSD was 1.0%,
n=6). The RSD of repeatability was 1.2% (
n=6). The
X-ray diffraction method is fast, sensitive and specific, and the full spectrum fitting internal standard quantitative method is of good accuracy and repeatability, which can solve the problem of determination of calcium carbonate content in
Xiaokening tablets.
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