Application of a Validated, Stability-Indicating LC Method to Stress Degradation Studies of Ramipril and Moexipril.HCl

Elshanawane, Abdalla A.; Mostafa, Samia M.; Elgawish, Mohamed Saleh

doi:10.1365/s10337-008-0544-3

Cited by 25 publications

(16 citation statements)

References 9 publications

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“…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].…”

Section: Moexipril Hydrochloride (Mox) Is Chemically (3s)-2-[(2s)-2-{mentioning

confidence: 99%

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

Kelani¹,

Shalaby²,

El-Maamly³

et al. 2014

Pharm Anal Acta

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In this study determination of Moexipril hydrochloride (MOX) and hydrochlorothiazide (HCT) were conducted by application of Spectrophotometric and Chemometric methods. Five different accurate, sensitive and reproducible methods were applied for the simultaneous determination of (MOX) and (HCT) in their bulk powder and pharmaceutical dosage form. The first method is the new absorbance subtraction (AS) method. The second method is the new amplitude modulation (AM) method. The third method is the new extended ratio subtraction (ERS) method coupled to ratio subtraction (RS) method. The fourth and fifth methods are multivariate calibration which includes Principal Component Regression (PCR) and Partial Least Squares (PLS). The suggested procedures were checked using laboratory prepared mixtures and were successfully applied for the analysis of their pharmaceutical preparations. The validity of the proposed methods was further assessed by applying the standard addition technique. The results obtained by applying the proposed methods were statistically analyzed and compared with a reported method.

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Section: Moexipril Hydrochloride (Mox) Is Chemically (3s)-2-[(2s)-2-{mentioning

confidence: 99%

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

Kelani¹,

Shalaby²,

El-Maamly³

et al. 2014

Pharm Anal Acta

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“…There are few works related with stability studies of ramipril: stress studies for the simultaneous determination of ramipril/moexipril 4 , ramipril/ telmisartan 5 , and ramipril/hydrochlorothiazide 6 , a forced degradation study of ramipril in Altace ® capsules 7 , a stability study of ramipril at different pH 8 , a study of stability of ramipril over time in water apple juice and applesauce 9 , and a comparative study of stability over time of marketed ramipril generics tablets versus reference ramipril tablets 10 . There are other works described in the literature but for the determination of ramipril and ramiprilat in biological samples 11,12 .…”

Section: Instrumentation and Chromatographic Conditionsmentioning

confidence: 99%

Stress Degradation Studies of Ramipril by a Validated Stability-Indicating Liquid Chromatographic Method

Diego¹,

Godoy²,

Mennickent³

et al. 2010

J. Chil. Chem. Soc.

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Ramipril is an angiotensin-converting enzyme inhibitor which has chemical structure susceptible to degradation, therefore in this work forced degradation studies of ramipril were carried out by a developed and validated stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under hydrolysis (0.1 N HCl, water and 0.1 N NaOH), oxidation (3% H 2 O 2 ), heat (70ºC) and photolysis (UV and VIS radiation). The drug was degraded under acidic, neutral, alkaline, oxidation and thermal stress conditions but it was stable under photolysis. Chromatographic separation of ramipril from its degradation products was achieved on a RP-18 column, using a mobile phase consisting of methanol -tetrahydrofuran -phosphate buffer (pH 2.4; 0.01M) (55:5:40, v/v/v) at a flow rate of 1.0 mL min −1 and UV detection at 215 nm. The assay was linear for ramipril concentrations of 50-300 µg/mL. The developed method was stability indicating, specific, accurate and precise for ramipril determination. This method was used to quantify ramipril in tablets. The results showed that the method described here is suitable for quantitative determination and the stability study of ramipril.

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“…Literature survey revealed that AT or AM or HZ was individually determined or in combination with other drugs by high-performance liquid chromatography (HPLC) [12][13][14][15][16][17][18][19][20][21][22]. The ternary mixture of AT, HZ, and AM was only determined by reversed-phase liquid chromatographic methods in pharmaceutical formulations using cyanopropyl and C18 columns [23,24]. HPLC-tandem mass spectrometry (MS/MS) and ultra-performance liquid chromatography (UPLC)-MS/MS methods were used for the simultaneous determination of diuretics and β-blockers in human urine [25] after pretreatment by a solid phase extraction (SPE).…”

Section: Introductionmentioning

confidence: 99%

Eco-Friendly Simultaneous Chromatographic Determination of Amiloride Hydrochloride, Atenolol, and Hydrochlorothiazide in Urine

Albishri

El‐Hady

Tayeb

2015

Acta Chromatographica

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Summary. Pharmaceutical industry concerned recently with eco-friendly analytical methods to reduce the environmental pollution. The using of toxic organic solvents for the analysis of drugs is critical. In the current work, several simple and less costly approaches such as micellar and/or cyclodextrin liquid chromatography were discussed. A new eco-friendly and simple chromatographic analysis of the ternary mixture of amiloride hydrochloride (AM), atenolol (AT), and hydrochlorothiazide (HZ) in urine by hydroxypropyl-beta-cyclodextrin (HP-β-CD) bonded stationary phase was investigated. The experimental conditions were optimized and validated based on International Conference on Harmonization (ICH) Q2R1 guidelines to detect analytes by isocratic mobile phase of phosphate buffer (5.0 mmol L −1 , pH 7.0) in the presence of 0.5 mL min −1 flow rate, 25.0 °C, and 280 nm. Linearity, accuracy, and precision were found to be acceptable over the concentration range of 0.05-20.0 μg mL −1 for AM, 0.05-50.0 μg mL −1 for AT and 0.05-50.0 μg mL −1 for HZ. The proposed method was precise, selective, and sensitive enough for the routine analysis of ternary mixture at therapeutic urine levels. The inclusion complexation and the appendant hydroxyl groups of HP-β-CD were considered the main reasons for assisting in adequate separation of the drugs. On the other hand, the presence of kosmotropic phosphate ions could solubilize the protein and could strengthen the selective inclusion of drugs inside HP-β-CD cavity. Urinary excretion studies showed that the detection of drugs is possible up to 24 h after their ingestion.

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Application of a Validated, Stability-Indicating LC Method to Stress Degradation Studies of Ramipril and Moexipril.HCl

Cited by 25 publications

References 9 publications

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

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

Stress Degradation Studies of Ramipril by a Validated Stability-Indicating Liquid Chromatographic Method

Eco-Friendly Simultaneous Chromatographic Determination of Amiloride Hydrochloride, Atenolol, and Hydrochlorothiazide in Urine

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