Validated HPTLC Method for Simultaneous Quantitation of Domperidone Maleate and Naproxen Sodium in Bulk Drug and Formulation

[摘要] This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous quantitation of Domperidone maleate (DOM) and Naproxen sodium (NAP) as the bulk drug and in tablet dosage form. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of toluene: methanol: acetone (8: 2: 2, v/v/v). Densitometric evaluation of the separated zones was performed at 266 nm. The two drugs were satisfactorily resolved with RF values 0.44 ± 0.02 and 0.56 ± 0.02 for DOM and NAP, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (20–140 ng.spot-1 for DOM and 500-3500 ng.spot-1 for NAP), precision (intra-day RSD 0.4–1.01 % and inter-day RSD 0.316–0.876 % for DOM, and intra-day RSD 0.488–1.329 % and interday RSD 0.450–1.026 % for NAP), accuracy (98.38 ± 0.55 % for DOM and 98.64 ± 0.49 % for NAP), and specificity, in accordance with ICH guidelines.

[学科分类] 分析化学

[关键词] High performance thin layer chromatography; densitometry; validation; quantification; domperidone maleate; naproxen sodium