Reddy J Mahesh, Jeyaprakash M R, Madhuri K, Meyyanathan S N, Elango K
Department of Pharmaceutical Analysis, J. S. S College of Pharmacy, (Off Campus College of JSS University, Mysore), Rock Lands, Ootacamund-643 001, India.
Indian J Pharm Sci. 2011 May;73(3):320-3. doi: 10.4103/0250-474X.93517.
A simple, sensitive and reproducible method was developed and validated for the simultaneous estimation of diethylcarbamazine and levocetirizine in its tablet formulation by reverse phase high performance liquid chromatography using Waters1515 HPLC with UV detector at the λ(max) of 224 nm, using Princeton Sphere-100 C(18) (250×4.6 mm. 5 μ) column. The mobile phase used was 20mM potassium dihydrogen orthophosphate buffer (pH: 3.2):acetonitrile (50:50 v/v) with isocratic flow (flow rate 1 ml/min) and the pH was adjusted with orthophosphoric acid. Losartan potassium was used as an internal standard. The compounds diethylcarbamazine, levocetirizine and losartan potassium were eluted at 2.12, 4.27 and 5.96 min, respectively. The peaks were eluted with better resolution. The method was accurate with assay values of 96.32 and 93.04% w/w, precise (%RSD) with intra-day 1.72 and 1.89 and inter-day 1.85 and 1.92, recoveries 102.86 and 101.1% w/w, which are very sensitive with limit of detections (LOD)'s 75, 50 ng/ml and limit of quantification (LOQ)'s 100, 75 ng/ml and linear with R(2) values 0.994 in the range of 5 to 30 μg/ml 0.1 to 1 μg/ml for diethylcarbamazine and levocetirizine, respectively. Hence this method can be applied for quantification of different formulations containing diethylcarbamazine and levocetirizine simultaneously.
建立并验证了一种简单、灵敏且可重现的方法，用于通过反相高效液相色谱法同时测定片剂制剂中的乙胺嗪和左西替利嗪。该方法使用沃特世1515高效液相色谱仪及紫外检测器，检测波长为λ(max) 224 nm，色谱柱为普林斯顿Sphere - 100 C(18)（250×4.6 mm，5μm）。流动相为20mM磷酸二氢钾缓冲液（pH：3.2）：乙腈（50:50 v/v），等度洗脱（流速1 ml/min），pH用正磷酸调节。氯沙坦钾用作内标。乙胺嗪、左西替利嗪和氯沙坦钾分别在2.12、4.27和5.96分钟洗脱。各峰洗脱分离度良好。该方法准确，含量测定值分别为96.32%和93.04% w/w；精密度（%RSD）日内为1.72和1.89，日间为1.85和1.92；回收率分别为102.86%和101.1% w/w；灵敏度高，检测限（LOD）分别为75、50 ng/ml，定量限（LOQ）分别为100、75 ng/ml；线性良好，乙胺嗪在5至30μg/ml范围内R(2)值为0.994，左西替利嗪在0.1至1μg/ml范围内R(2)值为0.994。因此，该方法可用于同时定量含有乙胺嗪和左西替利嗪的不同制剂。
