Stability Indicating HPLC Method for the Determination of Hydrochlorothiazide in Pharmaceutical Dosage form (original) (raw)
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Chromatography Research International, 2016
An HPLC-PDA method was developed and validated for the determination of hydrochlorothiazide in bulk and pharmaceutical formulation. The method was optimized selecting chromatographic conditions of 50 : 50 acetonitrile : water, Inertsil® column (ODS-3 250 mm × 4.6 mm 5 μm), 20 μL injection volume, flow rate of 1 mL/min at ambient temperature (30°C), and 272 nm. Another column of C18Zorbax® (Eclipse Plus, 4.6 × 250 mm, 5 μm) was tested showing no big difference in the method results. The method was validated giving good precision (RSD% < 1), acceptable linearity (R2 ≥ 0.9978), and low LOD and LOQ (0.5 and 1.7 μg/mL, resp.) on both columns. Successful application on pharmaceutical dosage tablet form gave high recovery of 99.93%. The method was compared with official BP and other reported methods. The proposed method is economic, simple, and rapid and hence can be employed for routine analysis in quality control laboratories.
IJPSM, 2021
Hydrochlorothiazide (HCT) is a diuretic drug that works to inhibit sodium and chloride reabsorption. Therefore, the determination of hydrochlorothiazide levels is essential for quality control, whether as raw material, in pharmaceutical preparations, biological fluids, or mixtures. Search information on the determination of hydrochlorothiazide content was carried out through Google Scholar with the keywords "hydrochlorothiazide," "determination," "pharmaceutical preparation," "biological matrix," "mixture." The results showed that the levels of hydrochlorothiazide as a raw material could be determined by high-performance liquid chromatography (HPLC), capillary zone electrophoretic (CZE), micellar electrokinetic capillary chromatography (MEKC), capillary electrophoresis, chemiluminescence, voltammetry, and quantitative point tests. Hydrochlorothiazide in a pharmaceutical dosage form can be determined by high-performance liquid chromatography, spectrophotometric, electroanalytic, thin layer chromatography (TLC) methods, voltammetry, and capillary zone electrophoresis. Hydrochlorothiazide in urine is determined by electrochemical method, and hydrochlorothiazide in human blood plasma is determined by liquid chromatography method. In contrast, the hydrochlorothiazide in mixtures with other substances can be determined using voltammetric methods and high-performance liquid chromatography.
A Validated Reversed-Phase HPLC Method for the Determination of Hydrochlorothiazide in Human Plasma
A simple and precise reversed-phase high performance liquid chromatography (HPLC) method for the determination of hydrochlorothiazide (HCT) in human plasma was developed and validated. Using hydroflumethiazide as an internal standard (IS), separation was achieved on Atlantis dC 18 column. The mobile phase, 10 mM monobasic potassium phosphate and acetonitrile (80:20, v: v), was delivered at a flow rate of 1.2 ml/min. The eluent was monitored by photodiode array detector, with the wavelength set at 272 nm. Plasma samples containing HCT and IS were extracted with methyl tert butyl ether and reconstituted in mobile phase. No interference in blank plasma or of commonly used drugs was observed. The relationship between the concentration of HCT in plasma and peak area ratio of HCT to the IS was linear over the range of 5-300 ng/ml. The intra-day and inter inter-day coefficient of variation and bias were < 3.7% and < 12.0%, and < 10.2% and < 7.8%, respectively. Mean extraction recovery of HCT and the IS from plasma samples were 70% and 90%, respectively. The method was applied to assess the stability of HCT under various conditions generally encountered in the clinical laboratory.
2010
A novel, safe, accurate and sensitive spectrophotometric method was developed using 2 M sodium acetate and 8 M Urea solution as hydrotropic solubilizing agent for the quantitative determination of poorly water-soluble hydrochlorothiazide in tablet dosage form. There were more than 55 and 70 fold enhancements in the solubility of hydrochlorothiazide increases in 2 M sodium acetate and 8 M Urea solution as compared to solubilities in distilled water. Hydrochlorothiazide shows maximum absorbance at 272 nm. Sodium acetate and urea did not show any absorbance above 240 nm, and thus no interference in the estimation was seen. Hydrochlorothiazide is obeyed Beer,s law in the concentration range of 10 t0 50μg/ml (r 2 = 0.999) in sodium acetate and 5 to 25 μg/ml (r 2 = 0.999) in urea with mean recovery 98.74 and 99.99% in sodium acetate and urea respectively. Proposed method is new, simple, economic, safe, rapid, accurate and reproducible. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values
Method development and validation of hydrochlorothiazide in tablet dosage form by UV spectroscopy
A simple, reproducible and efficient spectroscopic method development and validation of hydrochlorothiazide in tablet dosage form. The drug was ermined by using methanol as a solvent for this study, which is determined by spectrophotometrically at 224-nm.the percentage recovery study of the drug for the proposed method range from 99-100%w/v indicating no interferences of the tablet excipients, by using methanol as a solvent. Linearity was obtained in the concentration range 10-50 µg/ml for the hydrochlorothiazide with correlation coefficient of 0.9916. The result analysis was validated statistically and recovery studies confirmed the accuracy and precision of the proposed method.
HPLC determination of hydrochlorothiazide in urine after solid-phase extraction
Macedonian Pharmaceutical Bulletin, 2005
A simple, rapid and precise HPLC method has been developed for the assay of hydrochlorothiazide in urine. The clean-up of the urine samples was carried out by solid-phase extraction using HLB cartridges. Extraction recovery was 94.00-100.28 %. HPLC separation was performed with isocratic elution on Hypersil BDS C18 column (100 x 4.0 mm I.D., 3 µm particle size) protected with appropriate guard column. The mobile phase was 18 % acetonitrile and 0.025 mol/L solution of KH2PO4, pH 4 at flow rate of 0.3 mL/min. Detection of the substances was performed at 220 nm. The calibration curves were linear in the range of 2-50 µg/mL. The developed method is validated by checking its accuracy, precision and stability. The detection limit is 2 µg/mL hydrochlorothiazide. The method is proved to be convenient for routine analysis of hydrochlorothiazide in urine.
Validation of the method for hydrochlorothiazide assay in extemporaneous preparations
Žurnal organìčnoï ta farmacevtičnoï hìmìï, 2017
Extemporaneous preparations that contain hydrochlorothiazide are widely prescribed and used in different countries for treating adults and children. The feature of the preparation of such dosage forms is the use of substances and commercial drugs as a source of the active pharmaceutical ingredient. Aim. To validate the UV-spectroscopic assay method for determining hydrochlorothiazide in extemporaneous syrups and powders. Results and discussion. For method proposed the conditions of analysis, sample preparation and validation characteristics were determined. The samples of syrups and the powder were dissolved in 0.01 M sodium hydroxide solution and assessed by spectrophotometry in the ultraviolet region of light at the wavelength of 273 nm. The samples comply with the Beer-Lambert Bouguer law within the concentration range of 8 × 10-3-1.2 × 10-2 mg/ml with the the correlation coefficients ≥ 0.9992. The uncertainty of the methods was within the critical value of the error (the powder-1.14 %, the syrup-0.72 %) for both samples of the syrup containing the pure substance and commercial tablets. The assay method of hydrochlorothiazide in the extemporaneous preparations meets the acceptance criteria for the assay limits of ± 7.5 % and ± 10 % by such validation parameters as specificity, linearity, precision, accuracy within the range of 80-120 % of the nominal content. Experimental part. For research the volumetric glassware Class A, an UV-spectrophotometer (Thermoscientific Evolution 60S), analytical balances (AXIS ALN220), reagents and solvents corresponding to the requirements of the State Pharmacopoeia of Ukraine were used. Conclusions. The validation results have proven that the method can be reproduced correctly and is suitable for use in pharmaceutical analysis.
High-performance liquid chromatographic assay for hydrochlorothiazide in human urine
Journal of Chromatography B: Biomedical Sciences and Applications, 1986
A high-performance liquid chromatographic assay was developed for the quantitative determination of hydrochlorothiazide (HCT) in human urine. Reversed-phase separation of HCT and the internal standard, trlchloromethiazide (TCMT), was accomplished on a 300 x 3.9 mm NBondapak Phenyl column, Following solvent extraction, concentrations of HCT as low as 0.25 pgg/ml in urine were quantified by UV detection at 280 nm. Detector response (peak-area ratio of HCT to TCMT) was linear to 50 rglml. No interferences were observed in the extracts obtained from drug-free urine nor from several antihypertensive agents which are commonly co-administered with HCT. This method has been routinely employed in bioavailability studies evaluating a variety of formulations as well as characterizing the pharmacokinetics of thii drug from urinary excretion data.
SPECTROSCOPIC DETERMINATION OF HYDROCHLOROTHAIZIDE BY USING HYDROTROPIC SOLUBILISING AGENT
Analysis of drug utilized the organic solvent which are costlier, toxic, and causing environment pollution. Hydrotropic solution may be a proper choice to preclude the use of organic solvents so that an attempt has been made to develop simple, accurate, novel, safe and precise spectrophotometric method for estimation of poorly-water soluble drug Hydrochlorothaizide. Solubility of Hydrochlorothaizide is increased by using tri-sodium citrate and urea solution as hydrotropic agent. There was more than 28 fold solubility enhanced in hydrotropic solution as compare with distilled water. The Hydrochlorothaizide shows the maximum absorbance at 271 nm. At this wavelength hydrotropic agent and other tablet excipients do not shows any significant interference in the spectrophotometric assay. The developed method was found to be linear in the range of 5-25 μg/ml with correlation coefficient (r2) of 0.999. The mean percent label claims of tablets of Hydrochlorothaizide in marketed formulation estimated by the proposed method were found to be 99.91?0.04 respectively. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. As hydrotropic agent used in the proposed method so this method is eco-friendly and it can be used in routine quantitative analysis of drug in bulk drug and dosage form in industries