Dhaneshwar Suneela S, Deshpande P, Patil M, Vadnerkar G, Dhaneshwar S R
Department of Pharmaceutical Chemistry, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune-411 038, India.
Indian J Pharm Sci. 2008 Mar-Apr;70(2):233-6. doi: 10.4103/0250-474X.41463.
Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders. The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. The chromatographic separation was carried out on precoated silica gel 60 F254 aluminium plates using mixture of chloroform:methanol (8:1 v/v) as mobile phase and densitometric evaluation of spots was carried out at 235 nm using Camag TLC Scanner-3 with win CAT 1.3.4 version software. The experimental parameters like band size of the spot applied, chamber saturation time, solvent front migration, slit width etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with Rf value 0.11+/-0.01. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (40-200 ng/spot), precision (intra-day RSD 0.46-0.75%, inter-day RSD 0.46-1.59%), accuracy (98.72+/-0.20) and specificity according to ICH guidelines. The proposed method can analyse ten or more formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of duloxetine hydrochloride as bulk drug and in tablet formulation.
盐酸度洛西汀是一种有效的5-羟色胺和去甲肾上腺素双重再摄取抑制剂，用于治疗重度抑郁症。本研究描述了一种简单、精确且准确的HPTLC方法，用于测定其原料药及片剂剂型。色谱分离在预涂硅胶60 F254铝板上进行，以氯仿：甲醇（8:1 v/v）的混合物作为流动相，使用配备win CAT 1.3.4版本软件的Camag TLC Scanner-3在235 nm处对斑点进行光密度测定。对诸如点样斑点的带宽、展开缸饱和时间、溶剂前沿迁移、狭缝宽度等实验参数进行了严格研究，并确定了最佳条件。该药物得到了满意的分离，Rf值为0.11±0.01。根据ICH指南，通过评估各种验证参数，如线性（40 - 200 ng/斑点）、精密度（日内RSD 0.46 - 0.75%，日间RSD 0.46 - 1.59%）、准确度（98.72±0.20）和专属性，确定了该方法的准确性和可靠性。所提出的方法可以在单个板上同时分析十个或更多制剂单位，并为盐酸度洛西汀原料药及片剂剂型的常规分析提供了一种更快且经济高效的质量控制工具。
