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Validated capillary zone electrophoretic method for simultaneous analysis of benazepril in combination with amlodipine besylate and hydrochlorothiazide

Ahmed Hytham M., Belal Tarek S., Shaalan Rasha A., Yazbi Fawzy A., Elonsy Sohila M.

Acta Chromatographica

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2020

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Vol. 32, no. 4

219--227

EN

In this work, a novel, simple, and quick capillary zone electrophoresis (CZE) method was proposed for simultaneous analysis of benazepril (BEN) with other co-administrated antihypertensive drugs, amlodipine besylate (AML) and hydrochlorothiazide (HCT), using a diode array detector (DAD). A fused silica capillary (78.5 cm total length, 70 cm effective length, and 75 μm id) was used in separation using a 40 mM phosphate buffer pH 7.5 as a running background electrolyte (BGE) under a positive potential of 30 KV, at a stable temperature of 25 °C for capillary during separation. Hydrodynamic injections were performed for 12 s at 50 mbar, and detection was performed at 210 nm for AML and BEN, at 225 nm for HCT, and at 232 nm for xipamide (XIP) added as an internal standard (IS). Separation of the three analyzed drugs and the IS was performed in less than 8 min. Migration times were 4.06, 5.23, 6.69, and 7.3 min for AML, HCT, BEN, and XIP, respectively. The findings proved that the proposed method was linear in the range of 10–80 μg/mL for all drugs with correlation coefficients >0.9994. The limit of detection (LOD) values of AML, HCT, and BEN were 1.004, 1.224, and 0.896 μg/mL, respectively, whereas the limit of quantification (LOQ) values were 3.124, 3.727, and 2.749 μg/mL for the cited drugs, respectively. Peak identity and purity were confirmed by DAD. The developed CZE method was applied for the analysis of the three antihypertensive drugs successfully in their combined pharmaceutical tablets, and it can be used for the quality control of single-pill combination (SPC) samples of these drugs in short time.

2

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

Albishri H. M., El-Hady D., Tayeb R. A.

Acta Chromatographica

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2015

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Vol. 27, no. 3

461--476

EN

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.

3

Development of a New UPLC Method for Simultaneous Determination of Valsartan, Amlodipine Besylate, and Hydrochlorothiazide Pharmaceutical Products

Lahsini R., Monser L.

Acta Chromatographica

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2015

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Vol. 27, no. 3

449--460

EN

A new ultra-performance liquid chromatography method for the simultaneous determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations has been developed. Chromatographic separation was achieved within 1 min on a sub-2 μm RP18 column using an isocratic mode mobile phase consisting of a mixture of methanol and phosphate buffer (0.05 M, pH 3 ± 0.05) in the ratio 70:30 (v/v). The flow rate was set at 0.3 mL min-1 with a detection wavelength of 239 nm. The method was validated over the concentration ranges from 6.5 to 15.0 μg Ml -1 for hydrochlorothiazide, from 5.0 to 12 μg Ml-1 for amlodipine besylate and from 76.5 to 178.5 μg Ml-1 for valsartan. Calibration plots were linear for valsartan, amlodipine besylate, and hydrochlorothiazide with a correlation coefficient greater than 0.99. Relative variation coefficients for repeatability and reproducibility were less than 3.0%. Recoveries from standard addition essay of individual component in pharmaceutical formulations were varied from 97.0% to 102.0%. The proposed method was successfully applied for the determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations with recoveries with respect to label amount in pharmaceutical formulations that varied from 98.0% to 102.9%. The low flow rate, short analysis time, and simple mobile phase composition make the method cost effective, rapid, nontedious, and successfully employed for simultaneous determination of these drugs in commercial pharmaceutical products.

4

Validated RP-HPLC method for the simultaneous determination of amlodipine besylate, valsartan, and hydrochlorothiazide in bulk and in pharmaceutical formulation

Anandakumar K, Jothieswari D, Subathrai R, Santhi D. V, Vetrichelvan T

Acta Chromatographica

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2012

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Vol. 24, no. 1

37--50

EN

A reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of amlodipine besylate (AMB), valsartan (VAL), and hydrochlorothiazide (HCT) in pharmaceutical formulation using RP-C18 column. The mobile phase (acetonitrile:methanol:50 mM phosphate buffer adjusted to pH 3 with orthophosphoric acid) was pumped at a flow rate of 1.0 mL min-1 in the ratio of 20:50:30% v/v and the eluents were monitored at 239 nm. Linearity was obtained in the concentration range of 0.5–5 μg mL-1 for AMB, 4–40 μg mL-1 for VAL, and 1–10 μg mL-1 for HCT. The method was validated as per International Conference on Harmonization (ICH) guidelines and statistically. The method was validated for accuracy and precision. For precision, the coefficient of variance (COV) was found to be 0.3794, 0.1703 and 0.0578, and for accuracy, it was found to be 0.6351, 0.7688 and 1.1305 for AMB, VAL, and HCT, respectively. The COV values for all the drugs were found to be less than 2%, indicating high degree of precision and accuracy of the proposed high-performance liquid chromatographic (HPLC) method. Owing to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method can be applied for determining AMB, VAL, and HCT in bulk and in pharmaceutical dosage form.

5

Simultaneous RP-HPLC analysis of atenolol, hydrochlorothiazide, and losartan potassium in a tablet formulation

Thomas A. B, Chavan U. B, Nanda R. K, Kothapalli L. P, Jagdale S. N, Dighe S. B, Deshpande A. D

Acta Chromatographica

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2010

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Vol. 22, no. 2

219--226

EN

Simultaneous analysis of atenolol (Atn), hydrochlorothiazide (Hctz) and losartan potassium (Los) in solid dosage forms has been achieved by reversed-phase high-performance liquid chromatography on a C 18 column with a 0.035 M potassium dihydrogen orthophosphate-acetonitrile gradient as mobile phase and UV detection at 225 nm. The retention times for Atn, Hctz, and Los were 2.91, 4.75, and 7.52 min, respectively, with mean recoveries of 99.67, 99.89, and 100.69%. The method was validated in accordance with ICH guidelines. Because of its simplicity and high precision and accuracy, the method can be used for analysis of atenolol, hydrochlorothiazide and losartan potassium in pharmaceutical preparations.

6

Development and validation of a stability-indicating HPTLC method for analysis of nebivolol hydrochloride and hydrochlorothiazide in the bulk material and in pharmaceutical dosage forms

Damle M. C., Topagi K. S., Bothara K. G.

Acta Chromatographica

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2010

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Vol. 22, no. 3

433--443

EN

An accurate, sensitive, rapid, and precise stability-indicating high-performance thin-layer chromatographic (HPTLC) method for analysis of nebivolol hydrochloride and hydrochlorothiazide as the bulk drug and in tablets has been developed and validated. Optimum separation was achieved on silica gel 60 F 254 plates with ethyl acetate-methanol-acetic acid 6.5:1:0.5 ( υ/υ ) as mobile phase. Detection and quantification were performed at 280 and 270 nm for nebivolol hydrochloride and hydrochlorothiazide, respectively. The drugs get resolved with R F 0.46 ± 0.02 and 0.78 ± 0.02 for nebivolol hydrochloride and hydrochlorothiazide, respectively. The drugs were subjected to hydrolysis under acidic, basic, and neutral conditions, oxidation, heat, and photolysis as stress conditions. Peaks of degradation products were observed when the drugs were subjected to oxidative stress. Acidic conditions were also found to affect the tablet sample substantially. The degradation products resulting from stress conditions did not interfere with the drug peak. The method can be used for stability testing of these drugs during stability studies.

7

Simultaneous analysis of eprosartan and hydrochlorothiazide in tablets by high-performance thin-layer chromatography with ultraviolet absorption densitometry

Patel H. U., Suhagia B. N, Patel C. N.

Acta Chromatographica

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2009

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Vol. 21, no. 2

319--326

EN

A new, simple, accurate, and precise high-performance thin-layer chromatographic (HPTLC) method has been established for simultaneous analysis of eprosartan and hydrochlorothiazide in tablet formulations. Standard and sample solutions of eprosartan and hydrochlorothiazide were applied to precoated silica gel G 60 F 254 HPTLC plates and the plates were developed with benzene-methanol-formic acid 7:3:0.1 ( υ/υ ) as mobile phase. Detection and evaluation of chromatograms was performed densitometrically at 272 nm. The retention factors of eprosartan and hydrochlorothiazide were 0.76 and 0.57, respectively. The linear range was 4.8–43.2 μg per spot for eprosartan and 0.15–1.35 μg per spot for hydrochlorothiazide; the correlation coefficients, r , were 0.998 and 0.999, respectively. The method was validated and successfully used for analysis of the drugs in tablets.

8

Simultaneous analysis of ambroxol HCl with cetirizine HCl and of ambroxol HCl with levo -cetirizine dihydrochloride in solid dosage forms by RP-HPLC

Birajdar A. S., Meyyanathan S. N., Raja R. B., Krishanaveni N., Suresh B.

Acta Chromatographica

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2008

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Vol. 20, no. 3

411-421

EN

An isocratic RP-HPLC method has been developed and validated for simultaneous analysis of ambroxol hydrochloride (AMB) with cetirizine hydrochloride (CTZ) and of ambroxol hydrochloride (AMB) with levo -cetirizine dihydrochloride (LCTZ) in combined solid dosage forms. Formulations containing AMB with CTZ (tablets) and AMB with LCTZ (capsules) are used as antihistaminic H 1 blockers. Chromatography was performed on a 250 mm × 4.6 mm, 5-µm particle size, C 18 (ODS) column with a 45:30:30 ( v/v ) mixture of 30 mM aqueous ammonium sulphate (pH 5.5), acetonitrile, and methanol as mobile phase at a flow rate of 1 mL min -1 . The detection wavelength was 230 nm and analysis was performed at room temperature. Hydrochlorothiazide was used as internal standard for both formulations. Plots of drug-to-internal standard peakarea ratios (response factor) against respective concentrations were linear in the range 3 to 20 µg mL -1 for AMB and in the range 1 to 11 µg mL -1 for CTZ and LCTZ. The method was precise (RSD < 2) and accurate for analysis of both drugs in pharmaceutical dosage forms. Statistical data and results from recovery studies were reported for both formulations.