Baldania S L, Bhatt K K, Mehta R S, Shah D A
Anand Pharmacy College, Opp. Town Hall, Shri Ramkrishna Seva Mandal Campus, Anand-388 001, India.
Indian J Pharm Sci. 2008 Jul-Aug;70(4):494-7. doi: 10.4103/0250-474X.44601.
A simple, specific, accurate, and precise reverse phase liquid chromatographic method was developed and validated for the estimation of risperidone in tablet dosage forms. A Phenomenex Gemini C-18, 5 mum column having 250x4.6 mm i.d. in isocratic mode, with mobile phase containing methanol: acetonitrile: 50 mM potassium dihydrogen orthophosphate (80:10:10 v/v) was used. The flow rate was 1.3 ml/min and effluents were monitored at 234 nm. Clozapine was used as an internal standard. The retention time of risperidone and clozapine were 2.5 min and 3.3 min, respectively. The method was validated for linearity, accuracy, precision, specificity, limit of quantification, limit of detection, robustness and stability. The limit of detection and limit of quantification for estimation of risperidone was found to be 500 ng/ml and 990 ng/ml, respectively. Recovery of risperidone was found to be in the range of 99.02-101.68%. Proposed method was successfully applied for the quantitative determination of risperidone in tablet formulations.
开发并验证了一种简单、特异、准确且精密的反相液相色谱法，用于测定片剂剂型中的利培酮。使用 Phenomenex Gemini C-18 5μm 柱，内径 250×4.6 mm，等度洗脱模式，流动相为甲醇：乙腈：50 mM 磷酸二氢钾（80:10:10 v/v）。流速为 1.3 ml/min，在 234 nm 处监测流出物。使用氯氮平作为内标。利培酮和氯氮平的保留时间分别为 2.5 分钟和 3.3 分钟。该方法针对线性、准确度、精密度、特异性、定量限、检测限、稳健性和稳定性进行了验证。利培酮的检测限和定量限分别为 500 ng/ml 和 990 ng/ml。利培酮的回收率在 99.02 - 101.68% 范围内。所提出的方法成功应用于片剂制剂中利培酮的定量测定。
