Validated Chromatographic Methods for Determination of Hydrochlorothiazide and Spironolactone in Pharmaceutical Formulation in Presence of Impurities and Degradants

Abstract

Two specific, sensitive, and precise stability indicating chromatographic methods have been developed, optimized, and validated for Hydrochlorothiazide (HCT) and Spironolactone (SPR) determination in their mixtures and in presence of their impurities and degradation products. The first method was based on thin layer chromatographic (TLC) combined with densitometric determination of the separated spots. The separation was achieved using silica gel 60 F(254) TLC plates and ethyl acetate-chloroform-formic acid-triethyl amine (7:3:0.1:0.1, by volume) as a developing system. Good correlations were obtained between the integrated peak area of the studied drugs and their corresponding concentrations in different ranges. The second method was based on the high-performance liquid chromatography with ultraviolet detection, by which the proposed components were separated on a reversed phase C(18) analytical column using gradient elution system with deionized water-acetonitrile (97:3, v/v) for 8 min. Then acetonitrile was successively increased to 35% in the next 2 min, and kept constant in the following 10 min, finally 3% acetonitrile was regained again to stabilize the chromatographic system. The flow rate was maintained at 2 mL/min and the detection wavelength was at 230 nm. Linear regressions were obtained in the range of 4.0-50 μg/mL and 5.0-50 μg/mL for both HCT and SPR, respectively. Different parameters affecting the suggested methods were optimized for maximum separation of the cited components. System suitability parameters of the two developed methods were also tested. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for determination of HCT and SPR in their commercial tablets. Both methods were also statistically compared to each other and to the reported method with no significant difference in performance.

Analytical Techniques for Determination of Hydrochlorothiazide and its Combinations: A Review

“…Hegazy [34] developed and validated and stability indicating chromatographic methods for Hydrochlorothiazide (HCTZ) and Spironolactone (SPR) determination in their mixtures and in presence of their impurities and degradation products. The first method was based on thin layer chromatographic (TLC) combined with densitometric determination of the separated spots.…”

Spectrophotometric and Chemometric Methods for Simultaneous Determination of Two Anti-Hypertensive Drugs in their Combined Dosage Form

“…Spectroscopic [8][9][10], High Performance Liquid Chromatography (HPLC) [11][12][13], Thin Layer Chromatography (TLC) [14], Electrochemical [15][16][17] and mass spectrometry [18] methods for estimation of MOX alone or in combination with other drugs in pharmaceutical preparation have been reported. Hydrochlorothiazide alone or in combination with other drugs is estimated by HPLC [19][20][21][22][23][24][25][26][27][28][29], TLC-densitometry [30][31][32][33][34][35][36], capillary electrophoresis [37][38][39], electrochemical [40][41][42][43] and spectroscopic methods [44][45][46][47][48][49][50][51][52][53]. Simultaneous estimation of MOX and HCT has been reported by RP-HPLC [54,…”

Derivative spectrophotometric for simultaneous estimation of propranolol hydrochloride and hydrochlorothiazide in synthetic mixture

“…HCTZ and Valsartan were estimated by irst derivative method (Patel and ., 2012) The dual wavelengths and area under curve method were used for the simultaneous estimation of HCTZ and Olmesartan Medoxomil in their mixture (Ilango and Kumar, 2012). Both drugs were estimated by chro-matographic methods individually or simultaneously (Kim et al, 2001;Hegazy et al, 2011;Umamaheshwari and ., 2015). The Simultaneous Determination of Propranolol Hydrochloride and Isosorbide Mononitrate was done by Central Composite Rotatable Design (Khan et al, 2019).…”