Development and Validation of HPLC Method for Simultaneous Determination of Amlodipine, Valsartan, Hydrochlorothiazide in Dosage Form and Spiked Human Plasma

El-Gizawy, Samya M.; Abdelmageed, Osama H.; Omar, Mahmoud A.; Deryea, Sayed M.; Abdel‐Megied, Ahmed M.

doi:10.4236/ajac.2012.36055

Cited by 41 publications

(21 citation statements)

References 29 publications

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“…Previously described methods for determination of VAL (18)(19)(20) and CAN (21,22) in dosage forms were employed, with minor modifications. It was confirmed that the method was specific and accurate in the presence of syrup components.…”

Section: Analysis Of Drug Concentrationmentioning

confidence: 99%

Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Musko

Sznitowska

2014

Acta Pharmaceutica

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Available tablets or capsules for adults are often used to prepare extemporaneously formulated medicines appropriate for children. The most acceptable drug forms in pediatric population are oral liquids and pharmacists use commercial dispersing media to compound syrups from an active substance or from tablets available on the market. In many countries ready-to-use dispersing media are not available or refunded, but pharmacists can use other compounded media, providing their compatibility and stability are proven. The aim of this study was to formulate and evaluate the stability of syrups with candesartan cilexetil (1 mg mL-1) and valsartan (4 mg mL-1) extemporaneously prepared using commercial tablets (Diovan® and Atacand®). The following three different suspending media, which could be easily made in a pharmacy, were investigated: V1 - with xanthan gum (0.5 %), V2 - the USP/NF vehicle for oral solution and V3 - the medium based on a simple sucrose syrup. The stability of preparations was studied during 35 days of storage in a dark place at controlled temperature of 25 and 4 °C. During the study, microscopic observation was carried out and pH, viscosity, and concentration of candesartan cilexetil and valsartan were analyzed. Syrups with valsartan prepared with V2 and V3 media were stable for 3 or 4 weeks when stored at 25 °C, while syrups with candesartan were stable for as long as 35 days. For syrups prepared using V1 medium, the 14-day expiry date was not achieved because of microbial deterioration.

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Section: Analysis Of Drug Concentrationmentioning

confidence: 99%

Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Musko

Sznitowska

2014

Acta Pharmaceutica

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“…The derivative spectroscopy has also been applied for the determination of amlodipine and its photodegradant compound [8]. Chromatographic methods have been used widely for the analysis of AML, including thin layer chromatography (TLC) methods [9][10][11][12] and HPLC methods [13,14]. Capillary electrophoresis methods were also used for the analysis of AML in its formulations and biological fluids [15,16].…”

Section: Introductionmentioning

confidence: 99%

Untitled

2017

JAPLR

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A rapid, simple and sensitive high-performance liquid chromatographic (HPLC) method for determination of Amlodipine (AML) using sodium 1,2-naphthoquinone-4-sulfonate (NQS) has been developed. The method is based on the formation of a brown color product from the reaction between AML and NQS. The nucleophilic substitution reaction proceeds quantitatively at pH 13 buffer solution with absorption maximum at 465 nm. A C 18 column ODS (250mm×4.6mm), 5μm and a mobile phase of combination is potassium dihydrogen orthophosphate (0.05M) in water: acetonitrile (45:55%v/v) were used for separation and quantification. Analyses were run at a flowrate of 1.5mL/min and at 40 °C temperature. The injection volume was 20μL and the photodiode array detector was set at 465nm. Under these conditions Amlodipine-NQS eluted at 3.12 min. Total run time was shorter than 5 min. The developed method was validated according to the literature and found to be linear within the range 2-30μg /mL, describes by the regression equation y =207,082x +1,481.71 with a regression coefficient 0.999. The limit of detection and quantity are 0.01μg/mL and 0.04μg∕ mL respectively. This method is simple and can be applied for the determination of AML in pharmaceutical formulation in quality control laboratories.

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“…In combination with other drugs rosuvastatin has been determined by HPLC [17][18][19], chemometry in the presence of its degradation product [20].…”

Section: Introductionmentioning

confidence: 99%

Comparative Study of Rp-HPLC Method Versus Fourier Transform Convolution Chemometric Methods; An Application on Pharmaceutical Binary Mixtures of Candesartan Cilexetil-Pitavastatin Calcium and Clopidogrel Bisulfate-Rosuvastatin Calcium

Jamal

Gazy

2016

Int J Pharm Pharm Sci

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Objective: A comparative study of smart spectrophotometric chemometric assisted techniques and RP-HPLC for the determination of candesartan cilexetil (CAN)-pitavastatin calcium (PIT) and clopidogrel bisulfate (CLO)-rosuvastatin calcium (ROS), binary co-administered drugs were developed and validated. Methods:The spectrophotometric chemometric assisted methods included two simple techniques, namely Fourier transform convolution (FF) and ratio spectra of Fourier transform convolution (FFR) methods. FFR is considered as a hybrid divisor ratio spectra method where Fourier functions are applied to divisor ratio signals. The RP-HPLC method involves a rapid separation on a C18 column using a mobile phase consisting of acetonitrile: sodium dihydrogen phosphate (adjusted to pH 2.6 using orthophosphoric acid) in the ratio of 70:30 v/v at a flow rate of 1 ml/min in isocratic mode. CLO and ROS were monitored at 220 nm however CAN and PIT were monitored at 238 nm. Results:The spectrophotometric chemometric assisted methods proved their ability to quantify each of the studied drugs in their binary mixtures, where excellent percentage recoveries were obtained. FF and FFR method proved to be linear over the concentration range of 10-50 µg/ml for CLO, 4-20 µg/ml for ROS, 8-20 µg/ml for CAN and 2-10 µg/ml for PIT. The RP-HPLC method was able to separate the drugs in the study; retention times were found to be 3.9 min and 14.4 min for ROS-CLO, 4.2 min and 14.5 min for PIT-CAN respectively. The RP-HPLC method was found to be linear in the concentration range of 0.1-0.5 µg/ml for CLO, 0.04-0.2 µg/ml for ROS, 0.5-1 µg/ml for CAN and 0.05-0.1 µg/ml for PIT. System suitability parameters proved that peaks were well resolved from each other. Conclusion:The spectrophotometric and chromatographic methods were validated according to ICH guidelines. Recovery was found to be in the range of 95.9 %-100.5 % in synthetic laboratory mixtures. The suggested spectrophotometric methods have the advantage over other methods that they do not require a preliminary separation. Statistical analysis between the suggested spectrophotometric chemometric assisted and RP-HPLC methods, using student's t-and F-test revealed that there is no difference between the applied methods.

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Development and Validation of HPLC Method for Simultaneous Determination of Amlodipine, Valsartan, Hydrochlorothiazide in Dosage Form and Spiked Human Plasma

Cited by 41 publications

References 29 publications

Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Untitled

Comparative Study of Rp-HPLC Method Versus Fourier Transform Convolution Chemometric Methods; An Application on Pharmaceutical Binary Mixtures of Candesartan Cilexetil-Pitavastatin Calcium and Clopidogrel Bisulfate-Rosuvastatin Calcium

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