Stability study of losartan/hydrochlorothiazide tablets

Lusina, Maja; Cindrić, Tamara; Tomaić, Jadranka; Peko, Marijana; Pozaić, Lidija; Musulin, Nenad

doi:10.1016/j.ijpharm.2004.07.050

Cited by 50 publications

(24 citation statements)

References 21 publications

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“…The intra-day and inter-day precision was determined at three different concentrations (20,40 and 60 µg mL -1 ) in the linearity range. The data is represented in Table 2.…”

Section: Precisionmentioning

confidence: 99%

LC, LC-MS/MS studies for the identification and characterization of degradation products of hydrochlorothiazide and establishment of mechanistic approach towards degradation

Mahajan¹,

Thaker²,

Mohanraj³

2012

J. Braz. Chem. Soc.

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O objetivo do presente estudo foi separar, identificar e caracterizar os produtos de degradação de hidroclorotiazida, sob confições de estresse hidrolítico, oxidativo, fotolítico e térmico, conforme a diretriz Q1A (R2) da Conferência Internacional de Harmonização (ICH). A droga sofreu degradação sob estresse ácido, básico, neutro e oxidativo, enquanto permaneceu estável nas condições de estresse fotolítico e térmico. Dois produtos de degradação foram formados, os quais foram separados através de CLAE em coluna C18, usando um programa de eluição isocrática. Uma rota completa de fragmentação da droga foi estabelecida, primeiramente, com a ajuda de estudos de CL-EM/ EM. As amostras estressadas foram submetidas a estudos de CL-EM. Os dados dos espectros de massas foram empregados para caracterizar os produtos de degradação e atribuir estruturas. Os produtos de degradação foram identificados como 4-amino-6-cloro-1,3-benzenodissulfonamida e 6-cloro-2-oxi-3,4-diidro-2H-1,2,4-benzotiadiazina-7-sulfonamida-1,1-dióxido.The objective of the present investigation was to separate, identify and characterize the degradation products of hydrochlorothiazide under hydrolytic, oxidative, photolytic and thermal stress conditions as per the International Conference on Harmonization (ICH) guideline Q1A (R2). The drug degraded under acidic, basic, neutral and oxidative stress, while it was stable under photolytic and thermal stress conditions. Two degradation products were formed, which were separated by using HPLC on C18 column using isocratic elution program. A complete mass fragmentation pathway of the drug was first established with the help of LC-MS/MS studies. The stressed samples were subjected to LC-MS studies. The obtained mass spectral data were employed to characterize the degradation products and assign structures. The degradation products were identified as 4-amino-6-chloro-1,3-benzenedisulfonamide and 6-chloro-2-oxy-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

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“…The intra-day and inter-day precision was determined at three different concentrations (20,40 and 60 µg mL -1 ) in the linearity range. The data is represented in Table 2.…”

Section: Precisionmentioning

confidence: 99%

LC, LC-MS/MS studies for the identification and characterization of degradation products of hydrochlorothiazide and establishment of mechanistic approach towards degradation

Mahajan¹,

Thaker²,

Mohanraj³

2012

J. Braz. Chem. Soc.

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“…The retention times for OLME, AMLO and HCTZ were found to be 6.72, 4.28 and 2.30 respectively. Stability study of losartan / Hydrochlorothiazide tablets is presented by Lusina et al [47]. Losartan (angiotensin II receptor antagonist) and Hydrochlorothiazide (diuretic) are successfully used in association in the treatment of hypertension.…”

Section: Stability Indicating Chromatographic Methodsmentioning

confidence: 99%

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

Savaj¹,

Patidar²,

Raj³

2015

Int J of Adv in Sci Res

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Hydrochlorothiazide is chemically 6-chloro-1, 1-dioxo-3, 4-dihydro-2H-1, 2, 4-benzothiadiazine-7-sulfonamide. Hydrochlorothiazide is a diuretic drug used for treatment of high blood pressure (hypertension) and accumulation of fluid (edema). It works by blocking salt and fluid reabsorption from the urine in the kidneys, causing increased urine output (dieresis). Hydrochlorothiazide is used to treat excessive fluid accumulation and swelling (edema) of the body caused by heart failure, cirrhosis, chronic kidney failure, corticosteroid medications, and nephrotic syndrome. It can be used alone or in conjunction with other blood pressure lowering medications to treat high blood pressure.This review focuses on the recent developments in analytical techniques for estimation of Hydrochlorothiazide alone or in combinations with other drugs in various biological media like human plasma and urine. This review will critically examine the (a) sample pretreatment method such as solid phase extraction (SPE), (b) separation methods such as thin layer chromatography (TLC), high performance liquid chromatography (HPLC), ultra performance liquid chromatography (UPLC), high performance thin layer chromatography (HPTLC), liquid chromatography coupled to tandem mass spectrometry (LC-MS) and capillary electrophoresis (CE), (c) other methods such as spectrophotometry, diffuse reflectance near infrared spectroscopy and electrochemical methods.

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“…HCT and an α-adrenergic agonist (methyldopa) were determined by the same technique [19]. Earlier, stabilityindicating studies of HCT with other active pharmaceutical ingredients (APIs) were also reported [20]. The stability-indicating assay for VS and its degradation products in the active pharmaceutical ingredient and pharmaceutical dosage forms have been studied as well [21][22][23].…”

Section: Fig 1 Chemical Structures Of Hydrochlorothiazide and Valsamentioning

confidence: 99%

Total error-based validation including the experimental design-based robustness evaluation of a stability-indicating method for the simultaneous quantification of hydrochlorothiazide and valsartan in tablet formulations

Elkarbane¹,

AL-Kamarany²,

Bouchafra

et al. 2015

Acta Chromatographica

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Summary.A gradient reversed phase high-performance liquid chromatography (RP-HPLC) method with ultraviolet (UV) detection to analyze hydrochlorothiazide (HCT) and valsartan (VS) simultaneously in a tablet formulation during forced degradation studies was developed. This method was validated using a novel approach, namely, the accuracy profile or total errors approach. The robustness of the method was evaluated using a Plackett-Burman design for eight factors. The algorithm of Dong was applied to determine the significant factor effects. The validation results showed that the method is precise (RSD: 1.14% for HCT and 0.43% for VS) and accurate (mean recovery: 99.90% for HCT and 99.98% for VS). On the other hand, the results of the robustness study showed that the type of column was the important factor which affects a number of responses, namely, the asymmetry factor (AF), retention time (RT), and resolution (RS). However, the assay results were not affected; therefore, the method can be considered robust. Finally, the method was applied to study the stability of HCT and VS under forced conditions. Significant results were obtained with basic hydrolysis, oxidation, and thermal stress, while the accelerated and acidic conditions did not affect the stability of HCT or VS.

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Stability study of losartan/hydrochlorothiazide tablets

Cited by 50 publications

References 21 publications

LC, LC-MS/MS studies for the identification and characterization of degradation products of hydrochlorothiazide and establishment of mechanistic approach towards degradation

LC, LC-MS/MS studies for the identification and characterization of degradation products of hydrochlorothiazide and establishment of mechanistic approach towards degradation

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

Total error-based validation including the experimental design-based robustness evaluation of a stability-indicating method for the simultaneous quantification of hydrochlorothiazide and valsartan in tablet formulations

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