Objective: To establish an HPLC method for the simultaneous determination of reserpine, hydrochlorothiazide, dihydralazine sulfate, promethazine hydrochloride, vitamin B1, vitamin B6 and calcium pantothenate in compound reserpine tablets. Methods: HPLC experiment was performed on an column of Agilent Zorbax SB-C18(250 mm×4.6 mm,5 μm) with the mobile phase of acetonitrile(A)-0.03 mol·L-1 KH2PO4(containing 0.25% of heptanesulfonic acid sodium and adjust pH to 4.0 with phosphoric acid)(B) with gradient elution (0-7 min, 5%A→18%A; 7-15 min, 18%A; 15.1-23 min, 50%A; 23.1-30 min, 5%A). The flow rate was 1.0 mL·min-1, the column temperature was 40 ℃, and the detection wavelength was 205 nm(0-7 min for calcium pantothenate), 275 nm(7-17 min for hydrochlorothiazide, vitamin B6, dihydralazine sulfate, vitamin B1) and 215 nm(17-30 min for promethazine hydrochloride and reserpine). The injection volume was 20 μL. Results: Reserpine, hydrochlorothiazide, dihydralazine sulfate, promethazine hydrochloride, vitamin B1, vitamin B6 and calcium pantothenate showed good linear relationships with the peak area in the corresponding range (r＞0.999), the average recoveries of 9 samples at low, medium and high concentration levels were 99.8% (RSD=1.4%), 98.9%(RSD=1.5%), 100.4%(RSD=1.4%), 99.8%(RSD=1.0%), 99.2%(RSD=1.2%), 100.9%(RSD=1.1%), 100.2%(RSD=1.2%) respectively. The precision and stability were good with RSDs less than 2%. The contents of 7 components in film-coated tablets(6 manufacturing enterprises, a total of 17 batches) were between 93.0% and 108.2% of the labeled amount. The contents of 7 ingredients in sugar-coated tablets were between 75.2% and 108.0% of the marked amount. Conclusion: The established method is simple, rapid, specific for the quality control of compound reserpine tablets. It provides reference for improving the quality standards of compound reserpine tablets.
QIAN Min, SONG Dong-mei, LING Xia, LE Jian
. Simultaneous determination of the content of seven components in compound reserpine tablets by HPLC*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(7)
: 1110
-1119
.
DOI: 10.16155/j.0254-1793.2022.07.02
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