Abstract
A rapid specific RP-HPLC method has been developed for the determination of Lansoprazole impurities in the drug substance. The control of pharmaceutical impurities is currently a critical issue in the pharmaceutical industry. The International Council for Harmonization (ICH) has formulated a workable guideline regarding the control of impurities. The objective of the recent study was to develop and validate a HPLC method for the quantitative determination of process-related impurities of Lansoprazole in pharmaceutical drug substance. Lansoprazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl] methyl]-sulfinyl]- 1H-benzimidazole is an proton pump inhibitor used in the management of gastric ulcers. Chromatographic identification of the impurities was carried out by response surface methodology, applying a three-level Box Behnken design with three center points. Three factors selected were a mobile phase, flow rate, column temperature. Evaluation of the main factor, their interaction, and the quadric effect on peak resolution were done on Waters Symmetry C8, 250 x 4.6mm, 5µm column is used for the development of the method. The mobile phase consists of buffer and acetonitrile. The flow rate of the mobile phase was 1.0 ml/min with gradient elution. The column temperature is ambient and the detection wavelength is 235 nm. The injection volume was 10 µL. The method was validated as per ICH guidelines for linearity in the range of 50-150 µg/ml and the LOD & LOQ values obtained were 0.437×10-4 and 0.1325×10-3 µg/ml respectively which specifies the method's sensitivity. The proposed method was successfully used to determine the Lansoprazole impurities in drug substances.
Highlights
Lansoprazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl] methyl]-sulfinyl]- 1H-benzimidazole, which is an effective acid pump inhibitor acting at the acid secretory pathway of the parietal cell decreasing gastric acid secretion.[1]
It can be used for treatment of gastric ulcer, reflux esophagitis, duodenal ulcer, Zollinger-Ellison syndrome, especially for the inhibition of Helicobacter pylori
The %RSD of peak areas of chromatograms of impurities mixed lansoprazole was found to be less than 2%
Summary
Benzimidazole, which is an effective acid pump inhibitor acting at the acid secretory pathway of the parietal cell decreasing gastric acid secretion.[1]. In the overwhelming majority of the pharmacopoeial monographs, impurities in the active pharmaceutical ingredient are determined by selective (usually highperformance liquid chromatography (HPLC)) or non-selective (usually titrimetric or ultraviolet (UV) spectrophotometry) methods.[5] HPLC is undoubtedly the most important method in drugimpurity profiling. It is widely used for separating and quantifying impurities, and this technique is most frequently used coupled with spectroscopic methods in the identifying and elucidating the structure of impurities.[6,7] Analytical method development and validation play important roles in drug discovery, Drug Development, and Manufacture of pharmaceuticals. It involves the detection of the purity and toxicity of a drug substance
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