Abstract
BackgroundThe hypertension and cardiovascular ailments are the leading cause of deaths worldwide. The combination therapy was found to be effective on the cardiovascular illness by reducing the blood pressure. The indapamide and perindopril combination therapy showed excellent results on reducing high blood pressure. With this in mind, the stability indicating reverse phase UPLC method was developed for the simultaneous identification and quantification of indapamide and perindopril from human plasma. In this work, we developed a new solid phase extraction method for the extraction of indapamide and perindopril in human plasma. It is a simple, accurate, and selective method for the extraction of these two drugs from human plasma with elution time of 2 min. The extracted drugs were identified and quantified by using stability indicating UPLC method. The method showed high recovery rate as well as low detection and quantification limits of two drugs.ResultsA novel, simple, highly accurate, and precise stability indicating ultra-performance liquid chromatography (UPLC) method was developed for the identification and quantification of perindopril (PP) (brand name Coversyl) and indapamide (IP) (brand name Lorvas) from human plasma. In this UPLC method, HSS C18 column (100 × 2.1 mm, 1.8 μm) and mobile phase acetonitrile (ACN), 10 mM KH2PO4 buffer solution (pH 3.0) mixture was used in the ratio of 65:35. Colum temperature of 30 °C, flow rate of 1.0 mL per minute and UV wave length of 254 nm were used. PP and IP were eluted below 2 min runtime with high resolution. Solid phase extraction (SPE) method was used for the extraction of PP and IP from human plasma. Different solvents were used to extract the analyte from SPE such as ACN, methanol, acetone, tertiary butyl diethyl ether (TBDE), chloroform (CHCl3), and ethanol (EtOH). Among these, ACN gave good recovery percentages (94.56 to 101.58%). From the linearity graph, good correlation coefficient values of 0.9996 for PP and 0.9997 for IP were achieved. The coefficient variance values for intra and inter day precision is in between 1.08 and 12.5%. The LOD and LOQ values were determined by the signal to noise ratio method. LOD and LOQ values for IP and PP were found to be 8.6 and 33.5 ng/mL and 28.33 and 110.5 ng/mL respectively. The developed method was statistically validated as per ICH guidelines.ConclusionIn summary, a novel stability indicating UPLC-UV method was developed and validated for the simultaneous identification and quantification of perindopril and indapamide drugs in human plasma and tested the stability as per ICH guidelines. It is a simple, accurate, and specific method for the extraction of these two drugs from human plasma and eluted within 2 min runtime. The method showed high recovery rate as well as low detection and quantification limits of two drugs. The developed method is suitable for routine analysis as well as in bioanalytical and clinical studies.Graphical abstract
Highlights
The hypertension and cardiovascular ailments are the leading cause of deaths worldwide
The developed method is suitable for routine analysis as well as in bioanalytical and clinical studies
Among all the columns used in the current method, HSS C18 column (100×2.1 mm, 1.8 μm) was found to be suitable for getting adequate resolution, plate count, and tailing factors (indapamide (1.7) and perindopril (1.6)) for the drug molecules simultaneously
Summary
The hypertension and cardiovascular ailments are the leading cause of deaths worldwide. The indapamide and perindopril combination therapy showed excellent results on reducing high blood pressure. With this in mind, the stability indicating reverse phase UPLC method was developed for the simultaneous identification and quantification of indapamide and perindopril from human plasma. The method showed high recovery rate as well as low detection and quantification limits of two drugs Cardiovascular ailments such as hypertension and stokes are the most leading diseases to cause death worldwide. The chemical name of perindopril is (2S,3aS,7aS)-1[(2S)-2-{[(2S)-1-ethoxy-1-oxopentan-2-yl] amino}propanoyl]-octahydro-1H-indole-2-carboxylic acid It is an ethyl ester of non-sulphahydryl derivative and angiotensin converting enzyme (ACE) inhibitor, it selectively reduces the level of angiotensin I by converting it to angiotensin II due to the hydroxylation of perindopril to produce its active metabolite perindoprilat. It inhibits the angiotensin II activities like stimulation of aldosterone secretion in adrenal cortex and vasoconstrictions [11, 12]
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