Determination of Content and Content Uniformity of Minoxidil Tablets by HPLC / 中国药师

ABSTRACT

To establish an HPLC method for the determination of content and content uniformity of minoxidil tablets. Methods:An Xbridge C18 column (250 mm ×4.6 mm, 5 μm)was used with methanol-0.03 mol·L-1 KH2PO4 solution -triethyl-amine(60∶40∶0. 1)(adjusting pH to 3. 5 with phosphoric acid ) as the mobile phase. The flow rate was 1. 0 ml·min-1 and the detec-tion wavelength was 287 nm. The column temperature was 30℃ and the injection volume was 10 μl. Results:There was a good linear relationship within the range of 8. 056-32. 224 μg·ml-1(r=0. 999 9). The average recovery was 99. 68%(RSD=0. 36%,n=9). The average content of 3 batches of samples was 100. 2%,100. 5% and 99. 8% and the content uniformity was 5. 5,6. 2 and 4. 9, re-spectively. Conclusion:The method is simple and accurate with good reproducibility, which can be used in the quality control of mi-noxidil tablets.