article · International Journal of Applied Pharmaceutics
A rapid, economical, simple, and highly sensitive stability-indicating High-Performance Liquid Chromatography (HPLC) method was developed and thoroughly validated for the simultaneous determination of enalapril maleate and its related impurities, enalaprilat dihydrate and diketopiperazine. The method utilised a Grace Platinum C8 EPS column with a specific mobile phase and UV detection, achieving chromatographic separation in under nine minutes. Validation followed ICH guidelines, demonstrating excellent linearity, high sensitivity, and successful application for analysing enalapril maleate in tablet dosage forms. This validated method is suitable for routine quantitative analysis and quality control in pharmaceutical formulations.
Ensuring the quality and purity of pharmaceutical drugs like enalapril maleate is crucial for patient safety and treatment efficacy. This research provides a reliable and efficient analytical tool for pharmaceutical manufacturers and regulatory bodies to monitor drug formulations, helping to guarantee that medicines meet required standards.
This research presents an applied and tested analytical method for quality control in the pharmaceutical industry. It could be directly adopted by pharmaceutical manufacturing companies and contract testing laboratories for routine analysis and quality control of enalapril maleate tablets. The method's characteristics, such as being rapid, economical, and simple, make it attractive for industrial implementation in drug production and post-market surveillance.
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Objective: A simple, rapid, economical, and highly sensitive stability-indicating HPLC method was developed and fully validated for determination of enalapril maleate in presence of its related substances namely enalaprilat dihydrate and diketopiperazine.Methods: Chromatographic separation was achieved on Grace Platinumр C8 EPS column (4.6 mm i.d. X 250 mm, 5 μm) at room temperature. The mobile phase consisted of acetonitrile: 20 mmol phosphate buffer adjusted to pH 2.2 (25:75 v/v) isocratically pumped at a flow rate 2 ml/min and UV-detection was monitored at 215 nm.Results: The proposed method was validated according to ICH guidelines with total run time less than 9 min. The correlation coefficient (r2) was noted as 0.99981 which states that the method was good linear to the concentration versus peak area responses. The developed method found to be high sensitivity with LOD and LOQ of 0.021 and 0.062 %; respectively. The developed, validated method was successfully applied for the determination of enalapril maleate in presence of their impurities in tablet dosage form.Conclusion: A rapid, economical, simple and sensitive HPLC method was developed and validated for the determination of enalapril maleate in tablet dosage form in presence of their impurities. The developed method can help research studies, quality control and routine analysis with lesser resources available. Therefore, the proposed validated method is fast and reliable and can be used for routine quantitative analysis as well as quality control of enalapril maleate in pharmaceutical formulation.
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DOI: 10.22159/ijap.2018v10i1.22805
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