Heda A A, Kathiriya J M, Gadade D D, Puranik P K
Department of Pharmaceutics, Government College of Pharmacy, Osmanpura, Vedant Road, Aurangabad-431 005, India.
Indian J Pharm Sci. 2011 Nov;73(6):696-9. doi: 10.4103/0250-474X.100255.
A new simple, selective, rapid, precise and accurate reverse phase HPLC method has been developed for simultaneous estimation of granisetron and dexamethasone. The method was developed using CPS Hypersil CN column (250×4.6 mm I.D.) with a mobile phase consisting of acetonitrile:buffer (100 mM Triethylamine adjusted to pH 3.0 with o-phosphoric acid) in ratio of 25:75 at a flow rate of 2 ml/min. Detection was carried out at 242 nm. The developed method was evaluated for various system suitability parameters and validated for linearity, accuracy, precision, LOD, LOQ as per ICH guidelines. It was also evaluated for bench top stability and freeze/thaw stability. The proposed method can be used for the estimation of these drugs in their combined dosage forms.
已开发出一种新的简单、选择性强、快速、精确且准确的反相高效液相色谱法,用于同时测定格拉司琼和地塞米松。该方法采用CPS Hypersil CN柱(内径250×4.6 mm),流动相由乙腈:缓冲液(100 mM三乙胺用邻磷酸调至pH 3.0)按25:75的比例组成,流速为2 ml/min。检测波长为242 nm。对所开发的方法进行了各种系统适用性参数评估,并根据ICH指南对线性、准确度、精密度、检测限、定量限进行了验证。还对其台式稳定性和冻融稳定性进行了评估。所提出的方法可用于测定这些药物的复方制剂。