Abstract
Objective: To develop a simple, rapid, economic, accurate and precise reverse phase-high performance liquid chromatographic (RP-HPLC) method for the determination of hydrochlorothiazide and candesartan in the pharmaceutical dosage form and to validate as per international conference on harmonization (ICH) guidelines.Methods: The chromatographic separation was performed on Silanol BDS C18 column (250 x 4.6 mm, 5 μm), a mobile phase consisting of water (pH adjusted to 2.8 with orthophosphoric acid): acetonitrile (30:70 % v/v), with a flow rate 1 ml/min and the detection wavelength of 210 nm using photodiode array (PDA) detector.Results: The developed method resulted in elution of hydrochlorothiazide at 2.28 min and candesartan at 4.28 min. The calibration curves were linear (r2=0.999) in the concentration range of 6.25-18.75 μg/ml and 8-24 μg/ml for hydrochlorothiazide and candesartan respectively. The percentage recoveries were found to be 99.78-100.39 for hydrochlorothiazide and 99.87-100.64 for candesartan. The limit of detection (LOD) was found to be 0.410 μg/ml and 0.699 μg/ml for hydrochlorothiazide and candesartan respectively. The limit of quantitation (LOQ) was found to be 1.367 μg/ml and 2.330 μg/ml for hydrochlorothiazide and candesartan respectively.Conclusion: A simple, economic, accurate, precise, linear and rapid RP-HPLC method was developed for simultaneous quantitative estimation of hydrochlorothiazide and candesartan in bulk and pharmaceutical formulation and the method was validated as per ICH guidelines. Hence, the method holds good for the routine analysis of hydrochlorothiazide and candesartan in various pharmaceutical industries as well as in academics.
Highlights
Hydrochlorothiazide [fig. 1] is chemically 6-chloro-1,1-dioxo-3,4dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, belongs to the thiazide class of diuretics
There were few reverse phase-high performance liquid chromatographic (RP-HPLC) methods for the estimation of hydrochlorothiazide and candesartan[13,14,15,16,17] but the developed methods involve use of buffers as mobile phases which decrease the life of the column and has longer retention times, leading to more analysis time
Pharmaceutical grade hydrochlorothiazide and candesartan were provided as a gift sample by Spectrum Pharma Labs, Hyderabad and the marketed formulation (Candesar-H, candesartan-16 mg, hydrochlorothiazide-12.5 mg) was purchased from local market, acetonitrile, orthophosphoric acid and HPLC grade water purchased from Merck
Summary
Hydrochlorothiazide [fig. 1] is chemically 6-chloro-1,1-dioxo-3,4dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide, belongs to the thiazide class of diuretics. A detailed literature survey revealed that there were analytical methods for the estimation of specified drugs with other combinations by ultraviolet spectroscopy (UV) [1,2,3,4,5,6,7], high-performance thin layer chromatography (HPTLC) [8], liquid chromatography/mass spectrometry/mass spectrometry (LCMS/MS) [9] and HPLC [10,11,12]. There were few RP-HPLC methods for the estimation of hydrochlorothiazide and candesartan[13,14,15,16,17] but the developed methods involve use of buffers as mobile phases which decrease the life of the column and has longer retention times, leading to more analysis time. The developed method was validated as per validation of analytical procedures i.e. ICH guidelines: Q2 [R1] Validation of Analytical Procedures: Text and Methodology
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