Objective: To establish a quantitative analysis of crystal type Ⅰ content
in simvastatin tablets from two companies by powder X-ray diffraction (PXRD)and
comparative analysis of the contents of crystal type Ⅰ. Methods: The fine
scanning method was adopted. The scan range was 6-19°, the scan speed was 5 s
per step and the step size w a s 0.0 2°. Results: The linear equations
were Y=4.022×104X-3.536×103 (r=0.995
0) and Y=4.506×104X+19.54 (r=0.993 7)for
simvastatin tablets from two companies, respectively. The detection limit were
1.3 mg·g-1 and 1.6 mg·g-1. The quantitative limit were 6.6
mg·g-1 and 6.5 mg·g-1, respectively. The contents of
crystal type Ⅰ in simvastatin tablets were 60.5%-67.1% and 98.3%-100.5%,
respectively. There were significant differences of the contents of crystal type
Ⅰ in simvastatin tablets from two companies. Conclusion: The method is
simple in operation, which can be used for quantitative analysis of crystal type
Ⅰ content in simvastatin tablets with no interference of excipients. It can be a
rapid detection method for control crystal type Ⅰ content.
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