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

Abstract

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.