Abstract
Objective: Development and validation of new, simple and reliable enantioselective reverse phase ultra-fast liquid chromatography (RP-UFLC) method for quantification of chlorthalidone in bulk and pharmaceutical dosage form.Methods: In the present study, the isocratic RP-UFLC method was developed on Phenomenex® Lux cellulose 4 column (250×4.6 mm, 5µ) and di-sodium hydrogen phosphate buffer (pH 3.6): methanol (40:60 v/v) as mobile phase. Elute was monitored at 240 nm with a flow rate of 1 ml/min.Results: The described method provided linear correlation (R2=0.999) between the range of 2-10 µg/ml. Chlorthalidone enantiomers showed good resolution with a retention time (tR) of 5.75 min and 7.46 min respectively. The precision of the method revealed that relative standard deviation is within the acceptable limit. The percentage recovery of each chlorthalidone enantiomers was found to be 99.98% and 100.09% respectively. The method was validated in accordance with ICH harmonized tripartite guidelines, validation of analytical procedures: text and methodology Q2 (R1).Conclusion: An economical, accurate, sensitive and precise RP-UFLC method was developed and fully validated for quality control analysis of chlorthalidone in pharmaceutical dosage form.
Highlights
Chlorthalidone is (RS) 2-chloro-5-(1-hydroxy-3oxo-2, 3dihydro-1H-isoindol-1-yl) benzene-1-sulfonamide [fig.1]
Chlorthalidone is practically insoluble in water, but it is soluble in methanol
The linearity is a capability of the method to produce test results that are directly proportional to the concentration of an analyte in a given range as shown in fig
Summary
Chlorthalidone is (RS) 2-chloro-5-(1-hydroxy-3oxo-2, 3dihydro-1H-isoindol-1-yl) benzene-1-sulfonamide [fig.1]. Chlorthalidone is an oral diuretic drug widely used for the treatment of hypertension. It is described as a thiazide-like diuretic because it acts to the thiazides. Its molecular formula and the molecular weight is C14H11ClN2O4S and 338.766 g/mol respectively. It was more effective than amlodipine in reducing congestive heart failure (CHF) in the antihypertensive and lipid-lowering treatments to prevent heart attach trial (ALLHAT) [2]. Chlorthalidone prevents reabsorption of sodium and chloride by inhibiting the Na+/Cl− symporter in the distal convoluted tubule i.e.; it increases the rate of excretion of Na+and Cl from the body [3]
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