A stability-indicating LC method for the simultaneous determination of ramipril and hydrochlorothiazide in dosage forms

Belal, F.; Al-Zaagi, I.A; Gadkariem, Elrasheed A.; Abounassif, Mohammad A.

doi:10.1016/s0731-7085(00)00474-x

Cited by 69 publications

(24 citation statements)

References 17 publications

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“…HCT and an angiotensin-IIreceptor antagonist (candesartan, eprosartan mesylate, irbesartan, losartan potassium, telmisartan, and valsartan) were quantified by capillary electrophoresis and high-performance liquid chromatography (HPLC) [2][3][4][5][6][7][8][9]. HCT and angiotensin-converting enzyme inhibitors (cilazapril, quinapril, ramipril and enalapril) were measured by square wave voltammetry, ultraviolet (UV) spectroscopy, and HPLC [10][11][12][13]. HCT and a β-blocker (atenolol, metoprolol, nebivolol) were quantified using HPLC with UV and tandem mass spectrometry [14][15][16][17].…”

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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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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“…The methods [3][4][5][6][7][8][9][10][11] for telmisartan in combination with other drugs in plasma, serum and in tablets by high-performance liquid chromatography (HPLC) and [12][13][14][15][16][17] for the estimation of hydrochlorothiazide in combination with other drugs in serum and is in tablets by high-performance liquid chromatography (HPLC). A stability indicating LC method has been reported for telmisartan as well as hydrochlorothiazide.…”

Section: Telmisartan a Nonpeptide Molecule Is Chemically 4'-[(14-dmentioning

confidence: 99%

Stability - Indicating Lc Method for the Simultaneous Determination of Telmisartan and Hydrochlorothiazide in Dosage Form

Patil

Shinde

2012

J. Chil. Chem. Soc.

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A simple, rapid, and precise method is developed for the quantitative simultaneous estimation of telmisartan and hydrochlorothiazide in combined pharmaceutical dosage form. A chromatographic separation of the two drugs was achieved with an ACE 5 C 18 (250 x 4.6 mm) analytical column using buffer-acetonitrile (55:45 v/v). The buffer used in mobile phase contains 0.1M sodium perchlorate monohydrate in double distilled water pH adjusted 3.0 with trifluoroacetic acid. The instrumental settings are flow rate of 1.5 ml min -1 , column temperature at 30 o C, and detector wavelength of 215 nm using a photodiode array detector. The resolution between hydrochlorothiazide and telmisartan founds to be more than 5. Theoretical plates for hydrochlorothiazide and telmisartan were 13022 and 6629 respectively. Tailing factor for hydrochlorothiazide and telmisartan was 0.94 and 0.98 respectively. Telmisartan, hydrochlorothiazide and their combination drug products stressed samples were analysed by the proposed method. The described method shows excellent linearity over a range of 70 to 130% of target analyte concentration. The correlation coefficient for telmisartan and hydrochlorothiazide are 0.9999. The relative standard deviation for six measurements in two sets of each drug in tablets is always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and stability study of telmisartan and hydrochlorothiazide in pharmaceutical preparations.

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“…It is a diuretic and antihypertensive (7). A literature survey reveals that UV (8,9), HPLC (10)(11)(12)(13)(14)(15), and HPTLC (16,17) methods are reported for hydrochlorothiazide. No UV/Visible spectrophotometric method has been developed for this combination.…”

Section: Introductionmentioning

confidence: 99%

Ratio Spectra Derivative and Zero-Crossing Difference Spectrophotometric Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Combined Pharmaceutical Dosage Form

Rote¹,

Bari²

2009

AAPS PharmSciTech

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Abstract. Two simple, economical, rapid, precise, and accurate methods for simultaneous determination of olmesartan medoxomil and hydrochlorothiazide in combined tablet dosage form have been developed. The first method is based on ratio spectra derivative spectrophotometry, and the second method is zerocrossing difference spectrophotometry. The amplitudes in the first derivative of the corresponding ratio spectra at 231.0 and 271.0 nm were selected to determine olmesartan medoxomil and hydrochlorothiazide, respectively. Measurements of absorbance were carried out at zero-crossing wavelengths 257.8 and 240.2 nm for olmesartan medoxomil and hydrochlorothiazide by zero-crossing difference spectrophotometric method. Beer's law is obeyed in the concentration range of 08-24 µg/mL for olmesartan medoxomil (OLM) and 05-15 µg/mL for hydrochlorothiazide (HCT) by ratio spectra derivative and 05-30 µg/mL for OLM and HCT by zero-crossing difference spectrophotometric method. The results of the assay were found to be 100.46±0.95 for OLM and 100.4±0.27 for HCT by ratio spectra derivative and 99.06±1.14 for OLM and 100.05±0.90 for HCT by zero-crossing difference spectrophotometric method. These methods passes F test and t test. Both methods were validated statistically and by performing recovery study.

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A stability-indicating LC method for the simultaneous determination of ramipril and hydrochlorothiazide in dosage forms

Cited by 69 publications

References 17 publications

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

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

Stability - Indicating Lc Method for the Simultaneous Determination of Telmisartan and Hydrochlorothiazide in Dosage Form

Ratio Spectra Derivative and Zero-Crossing Difference Spectrophotometric Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Combined Pharmaceutical Dosage Form

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