Abstract
A selective, accurate, and precise stability-indicating HPLC method for analysis of levamisole hydrochloride in bulk and in their injection and oral solution formulations has been developed and validated in accordance with ICH guidelines. The chromatographic separation was carried out on a C8 column (250 × 4.6 mm with a particle size of 5 micrometer) using a mixture of phosphate buffer pH 8.0 and acetonitrile (70 : 30 v/v) as the mobile phase pumped at a flow rate of 1.5 ml/min with UV detection at 215 nm. The calibration curve was linear over the 10–50 μg/ml concentration range with a correlation coefficient of 1.0000. The limit of detection (LOD) and the limit of quantitation (LOQ) were 0.29 μg/ml and 0.89 μg/ml, respectively. The accuracy and the precision of the developed method were significantly good (RSD < 2%). The validity of the proposed method was further confirmed through the statistical comparison of the obtained data with those of the official method.
Highlights
Levamisole hydrochloride (Figure 1) has anthelmintic and immunomodulating activities
Various methods were reported for determination of levamisole hydrochloride in human and animal biological fluids, they still have some disadvantages. e British Pharmacopeia method for the analysis of the levamisole oral solution and injection was based on the nonaqueous titration after extracting the active ingredient using perchloric acid as the titrant and the toxic extracting solvent chloroform
It is well known that the nonaqueous titrimetric method has many drawbacks including using of large amount of sample and reagents, requiring a greater level of operator skill than routine instrumental methods, and nonselective and inaccuracy due to possible interference from the related substances, impurities, and degradation products leading to false results
Summary
Levamisole hydrochloride (Figure 1) has anthelmintic and immunomodulating activities. Literature review revealed that other analytical methods were used for the determination of levamisole in different dosage forms, including direct spectrophotometry at 215 nm [5], spectrophotometry after ion-pair extraction [6, 7], reversed-phase liquid chromatography [8, 9], thin-layer chromatography [10], and high-performance thin-layer chromatography [11]. Various chromatographic methods for its determination in animal and human biological fluids were reported [12,13,14,15,16,17]. We are reporting a simple, cost-effective, accurate, and precise stability-indicating high-performance liquid chromatographic method for the determination of levamisole in the presence of its degradation products
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