Content and dissolution determination of sGC-003 tablet by HPLC / 国际药学研究杂志

ABSTRACT

Objective To establish a high performance liquid chromatography (HPLC) method for determining the content and dissolution of soluble guanylate cyclase(sGC) - 003 tablets. Methods Content and dissolution of sGC- 003 tablets were determined by HPLC. Phenomenex Luna C18 column(250 mm×4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-water(40∶60, V/V), with a flow rate of 1.0 ml/min, and the detection wavelength was set at 214 nm. The column temperature was 40 ℃ and the injection volume was 20 μl(injection volume of dissolution was 80 μl). Dissolution of sGC-003 tablets was determined by the second method described in Chinese Pharmacopoeia(ChP) 2015. 900 ml of pH 4.5 acetic acid buffer, pH 6.8 phosphoric acid buffer and water were used as dissolution media at the rotation speeds of 50 and 75 r/min to select the dissolution condition. Results This method had high specificity. The average recovery was about 99.58%(RSD=0.75%, n=9). And the working solution was stable within 12 h. The calibration curves were had good linearity (R2=1) within the concentration range of 0.25-50 μg/ml. The method of dissolution tests for sGC-003 tablets was established that 900 ml pH 6.8 phosphoric acid buffer was used as dissolution medium and paddle rotation speed was 50 r/min. The dissolution would be 80% at 30 min. Conclusion The dissolution condition can be used to determine the dissolution of sGC-003 tablets. The HPLC method is convenient, fast, sensitive and accurate in determining the content and dissolution of sGC-003 tablets.