Abstract
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.
Highlights
Enalapril maleate is chemically described as (2S)-1-[(2S)-2-[[(1S)-1(Ethoxycarbonyl)-3-phenylpropyl] amino] propanoyl] pyrrolidine-2carboxylic acid (Z)-butenedioate
angiotensin-converting enzyme (ACE) is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II
Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decrease aldosterone secretion [1]
Summary
Enalapril maleate is chemically described as (2S)-1-[(2S)-2-[[(1S)-1(Ethoxycarbonyl)-3-phenylpropyl] amino] propanoyl] pyrrolidine-2carboxylic acid (Z)-butenedioate (fig. 1). Enalapril maleate is chemically described as (2S)-1-[(2S)-2-[[(1S)-1(Ethoxycarbonyl)-3-phenylpropyl] amino] propanoyl] pyrrolidine-2carboxylic acid (Z)-butenedioate Enalapril maleate is a prodrug which metabolized rapidly in the liver to ethyl ester of a long-acting enalaprilat which inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II stimulates aldosterone secretion by the adrenal cortex. The beneficial effects in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decrease aldosterone secretion [1]
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