Singh R M, Saini P K, Mathur S C, Singh G N, Lal B
Research and Development Division, Indian Pharmacopoeia Commission, Sector-23, Rajnagar, Ghaziabad-201 002, India.
Indian J Pharm Sci. 2010 Mar;72(2):235-7. doi: 10.4103/0250-474X.65023.
The present work describes a simple, precise and accurate HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form. The separation was achieved by using octadecylsilane column (C18) and acetonitrile:1 mM sodium acetate adjusted to pH 6.3 with acetic acid in proportion of 90:10 v/v as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 285 nm. The retention time of montelukast sodium was found to be 3.4 min. The limit of detection was found 1.31 µg/ml and limit of quantification 3.97 µg/ml. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (1-100 µg/ml), precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of montelukast sodium in bulk and in tablet dosage form.
本研究描述了一种用于测定孟鲁司特钠原料药和片剂剂型的简单、精确且准确的高效液相色谱法。采用十八烷基硅烷柱（C18），以乙腈：用乙酸调节pH至6.3的1 mM醋酸钠（体积比90:10）作为流动相，流速为1.5 ml/min，实现分离。检测波长为285 nm。发现孟鲁司特钠的保留时间为3.4分钟。检测限为1.31 µg/ml，定量限为3.97 µg/ml。根据ICH指南，通过评估线性（1 - 100 µg/ml）、精密度、准确度和专属性等各种验证参数，确定了该方法的准确性和可靠性。该方法为孟鲁司特钠原料药和片剂剂型的常规分析提供了一种准确且精确的质量控制工具。
