Das Gupta V, Stewart K R
Am J Hosp Pharm. 1982 Feb;39(2):292-4.
The stability of haloperidol in 5% dextrose injection using a high-pressure liquid chromatographic (HPLC) method is reported. A solution of haloperidol 10 mg/dl in 5% dextrose injection was prepared using commercially available haloperidol injection. The solution was stored at 24 degrees C, half in an amber glass bottle and half in a plastic bag. These were assayed on days 0, 1, 7, 14, and 38. Solutions prepared from commercial dosage forms of haloperidol (injection, oral liquid concentrate, and tablets) were assayed to verify the accuracy of the HPLC assay to quantify haloperidol. There was no loss of haloperidol potency in 38 days when stored 24 degrees C in either the amber glass bottle or plastic bag. There was a substantial loss of methylparaben and propylparaben (present in commercial haloperidol injection) in the solution stored in the plastic bag. Oxidation products of haloperidol did not interfere with the assay, and the HPLC assay accurately measured haloperidol in solutions prepared from commercial dosage forms. The results show that haloperidol 10 mg/dl in 5% dextrose injection was stable for at least 38 days. While the loss of parabens is not of practical importance, the HPLC method developed provided this information while the previously used USP-NF procedure did not. The assay can be used to quantify haloperidol in commercial dosage forms.
报道了采用高压液相色谱（HPLC）法测定氟哌啶醇在5%葡萄糖注射液中的稳定性。使用市售氟哌啶醇注射液配制5%葡萄糖注射液中含氟哌啶醇10mg/dl的溶液。该溶液在24℃下储存，一半置于琥珀色玻璃瓶中，一半置于塑料袋中。分别在第0、1、7、14和38天进行测定。对市售剂型（注射液、口服浓缩液和片剂）的氟哌啶醇所制溶液进行测定，以验证HPLC法对氟哌啶醇定量分析的准确性。在24℃下，无论是储存在琥珀色玻璃瓶还是塑料袋中，氟哌啶醇在38天内效力均无损失。储存在塑料袋中的溶液中，对羟基苯甲酸甲酯和对羟基苯甲酸丙酯（存在于市售氟哌啶醇注射液中）有大量损失。氟哌啶醇的氧化产物不干扰测定，HPLC法能准确测定市售剂型所制溶液中的氟哌啶醇。结果表明，5%葡萄糖注射液中含氟哌啶醇10mg/dl至少在38天内是稳定的。虽然对羟基苯甲酸酯的损失并无实际重要性，但所建立的HPLC法能提供此信息，而先前使用的美国药典-国家处方集方法则不能。该测定法可用于定量分析市售剂型中的氟哌啶醇。
