Gondhale-Karpe Priyanka, Manwatkar Sonali
Vishwakarma University, VU School of Pharmacy, Department of Pharmaceutical Chemistry & Analysis, Pune, 411048 Maharashtra, India.
Heliyon. 2023 Apr 28;9(5):e15732. doi: 10.1016/j.heliyon.2023.e15732. eCollection 2023 May.
Lamotrigine extended release tablet dosage form LAMICTAL XR used as an anticonvulsant in the treatment of generalized tonic clonic, absence seizures and partial seizures. The objective of the present study is to develop and validate analytical method for the estimation of related substances in the LAMICTAL XR from GSK; however it is very important to have simple, sensitive, robust and validated analytical method. Hence a precise RP-HPLC analytical method developed for the determination of Related substances in LAMICTAL XR tablet dosage form with gradient elution pattern having mobile phase A as buffer pH 8.0 and mobile phase B as an Acetonitrile at 1.5 mL/min flowrate, using Hypersil BDS C18 column, ambient column temperature and PDA detector with wavelength 220 nm. The analytical method is validated as per ICH guidelines including its forced degradation studies. The method was found to be linear in the range of 0.2 ppm to 2.5 ppm with correlation coefficient 0.999. Accuracy performed at LOQ to 250% level and recovery was found to be in the range of 95% to 105%. Therefore the developed related substances method provides a safe, easy and reproducible for the stability studies and QC release testing for the estimation of related substances.
拉莫三嗪缓释片剂型拉莫三嗪缓释片（LAMICTAL XR）用作抗惊厥药，用于治疗全身性强直阵挛性发作、失神发作和部分性发作。本研究的目的是开发并验证一种分析方法，用于测定葛兰素史克公司生产的拉莫三嗪缓释片中的有关物质；然而，拥有一种简单、灵敏、稳健且经过验证的分析方法非常重要。因此，开发了一种精确的反相高效液相色谱（RP-HPLC）分析方法，用于测定拉莫三嗪缓释片剂型中的有关物质，采用梯度洗脱模式，流动相A为pH 8.0的缓冲液，流动相B为乙腈，流速为1.5 mL/min，使用Hypersil BDS C18色谱柱，柱温为室温，采用波长为220 nm的光电二极管阵列（PDA）检测器。该分析方法按照国际人用药品注册技术协调会（ICH）指南进行了验证，包括强制降解研究。该方法在0.2 ppm至2.5 ppm范围内呈线性，相关系数为0.999。在定量限（LOQ）至250%水平进行了准确度测定，回收率在95%至105%范围内。因此，所开发的有关物质分析方法为有关物质的稳定性研究和质量控制放行检测提供了一种安全、简便且可重现的方法。
