Objective To study the dissolution medium of clindamycin palmitate hydrochloride dispersible tablets and clindamycin palmitate hydrochloride for suspension, and develop dissolution methods by HPLC. Methods The dissolution medium was 0.4% sodium dodecyl sulfate. Blender 2 was used with 75r/min.The dissolution medium of clindamycin palmitate hydrochloride dispersible tablets and clindamycin palmitate hydrochloride for suspension were separately taken and analyzed by HPLC after 20 minutes and 15 minutes. Results The standard curve was linear in the range of 15~115ug/mL (r=0.9999). The average recoveries were 99.1% (RSD=0.9%, n=9)for clindamycin palmitate hydrochloride dispersible tablets and 103.1% (RSD=2.9%, n=9) for clindamycin palmitate hydrochloride for suspension.The dissolutions of products from different factories were over 75%. Conclusion The method is simple and rapid, the results are accurate and reproducible.%目的 研究盐酸克林霉素棕榈酸酯分散片和干混悬剂的溶出介质,建立了高效液相色谱法测定盐酸克林霉素棕榈酸酯分散片和干混悬剂的溶出度.方法 以0.4％十二烷基硫酸钠溶液为溶出介质,桨法,转速为75r/min,分散片和干混悬剂分别在20min和15min时取样,取样后采用HPLC法测定.结果 盐酸克林霉素棕榈酸酯在15～115μg/mL的范围内呈良好的线性关系(r=0.9999),盐酸克林霉素棕榈酸酯分散片的平均回收率为99.1％(RSD=0.9％,n=9),盐酸克林霉素棕榈酸酯干混悬剂的平均回收率为103.1％(RSD=2.9％,n=9),溶出液稳定,分散片2批在20min时和干混悬剂3批在15 min时平均溶出度均在75％以上并且有较好的均一性.结论 该方法快速、简便,结果准确可靠,重现性好.
展开▼
