Analytical Method Development and Validation for Known and Unknown Impurities Profiling for Carvedilol Pharmaceutical Dosage Form (Tablets)

Mahajan, Nitin; Deshmukh, Suparna; Farooqui, Mazahar

doi:10.22159/ijcpr.2021v13i6.1922

Cited by 3 publications

(6 citation statements)

References 15 publications

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“…3). The total analysis time of this method was 15 min, which was faster than the results reported by Raju, Mahajan and Rao [23,26,27] , in which the analysis time was 20, 60 and 70 min respectively.…”

Section: Resultsmentioning

confidence: 60%

“…Accordingly, the United States Pharmacopoeia (USP) 41 have established maximum allowed limits for individual carvedilol related compound as not more than 0.02 % (impurity C) or 0.1 % (impurity A, B, D, E) in bulk and as not more than 0.2 % (each impurity) in tablets [16] . Several analytical methods for the estimation of carvedilol in tablets were reported in USP 41, British Pharmacopoeia (BP) 2018 and many literatures, such as Liquid Chromatography-Mass Spectrometry (LC-MS), High Performance Liquid Chromatography (HPLC), High-Performance Thin-Layer Chromatography (HPTLC) with Ultraviolet (UV) detector or Gas Chromatography-Mass Spectrometry (GC-MS) [16][17][18][19][20][21][22][23][24] . Amongst them, there were not many reports on the simultaneous determination of carvedilol and its impurities.…”

mentioning

confidence: 99%

“…Amongst them, there were not many reports on the simultaneous determination of carvedilol and its impurities. These procedures have some disadvantages, such as only analyzing carvedilol [19][20][21][22]24] , analyzing two or four impurities [17,23] , applying of solvent gradient program [16,18,23] , long analysis time [16,18,23] , or high Limit of Detection (LOD) and Limit of Quantitation (LOQ) values [19,22] . Hence, this study aimed to develop an isocratic reverse-phase HPLCdiode array detection method for the simultaneous determination of carvedilol and five impurities (A, B, C, D and E) (fig.…”

mentioning

confidence: 99%

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Simultaneous Determination of Carvedilol and its Impurities in Tablets by High Performance Liquid Chromatography

Nguyen¹,

Ho²,

Truong³

et al. 2022

IJPS

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Nguyen et al.: Determination of Carvedilol and its ImpuritiesThis study aimed to develop a simple and fast reverse-phase high performance liquid chromatographydiode array detection method for the simultaneous determination of carvedilol and five impurities (A, B, C, D, E) in tablets. The separation was carried out by Zorbax Eclipse XDB-C8 (150×4.6 mm; 5 µm) column. Isocratic elution was carried out using a mobile phase mixture of acetonitrile and phosphate buffer pH 2 (containing 1.5 mM 1-heptanesulfonic acid) in the ratio of 43:57 (v/v); while the flow rate was maintained at 0.7 ml/min. The impurity E was detected at 220 nm, carvedilol and other impurities were detected at 240 nm by a photodiode array detector. The good linearity was obtained with correlation coefficients (r 2 ) greater than 0.995 in the range of 0.01-1500 µg/ml for carvedilol, 0.04-3.0 µg/ml for impurity A and 0.1-3.0 µg/ml for impurities B, C, D, E. Inter-day and intra-day accuracy and precision data were within the acceptable limits. This new method has satisfactory applications in the quality control of pharmaceuticals containing carvedilol.

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Section: Resultsmentioning

confidence: 60%

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confidence: 99%

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confidence: 99%

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Simultaneous Determination of Carvedilol and its Impurities in Tablets by High Performance Liquid Chromatography

Nguyen¹,

Ho²,

Truong³

et al. 2022

IJPS

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“…The solution again diluted to obtain a solution of 100, 100 and 4 µg/ml for Clarithromycin, Amoxicillin, and Vonoprazan correspondingly. After injecting a volume of 10 µl of the prepared solution above, chromatograms were obtained and then assessed to determine the amounts of Clarithromycin, Amoxicillin, and Vonoprazan that had been degraded by comparing them to the control solution [26].…”

Section: Photodegradationmentioning

confidence: 99%

A Reliable Rp-Uplc-Tuv Method for Simultaneous Estimation of Clarithromycin, Amoxicillin, and Vonoprazan in Co-Packed Pharmaceutical Dosage Forms: Method Development and Validation With Stability Indicating Properties

ANUSHA,

SOWJANYA

2024

Int J App Pharm

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Objective: The study aims to develop a reliable RP-UPLC-TUV method for simultaneous estimation of Clarithromycin, Amoxicillin, and Vonoprazan in bulk and combined dosage. Methods: A simple, specific, and reliable method for determining Clarithromycin, Amoxicillin, and Vonoprazan has been developed using the RP-UPLC method. In order to successfully separate Clarithromycin, Amoxicillin, and Vonoprazan, 1.0 µl of a 100 % level solution was injected into a Hibar C18 (100 x 2.1 mm and 2 µm) column. The mobile phase consisted of Ammonium Acetate and Acetonitrile in equal volumes, and the flow rate was kept at 0.3 ml/min while the detection wavelength was set to 210 nm. Both the column and the injection port were kept at a temperature of 30 °C at all times. Results: The retention time (RT) of Clarithromycin, Amoxicillin, and Vonoprazan was observed at 1.24 min, 0.97 min and 1.66 min, correspondingly with accepted system suitability. The linear responses were observed for Clarithromycin, Amoxicillin, and Vonoprazan in the range of 25 to 150 µg/ml, 25 to 150 µg/ml and 1 to 6 µg/ml, respectively. The LOD and LOQ values were calculated to 0.07 µg/ml and 0.22 µg/ml for Clarithromycin, 0.81 µg/ml and 2.45 µg/ml for Amoxicillin and 0.03 µg/ml and 0.09 µg/ml for Vonoprazan. The % RSD values of both precision were assessed in the range of 0.8-1.4. The mean recovery of Clarithromycin, Amoxicillin, and Vonoprazan was in the range of 99.66 %-100.88 %. The statistical analysis of the validation parameters confirmed that the approach was reliable in terms of its accuracy, sensitivity, and precision while also exhibiting a high degree of sensitivity. The study of analytes in a variety of stressful situations guarantees the stability of the substances, ensuring that they represent the method's stability indication. Conclusion: The newly established technique is quite effective in separating Clarithromycin, Amoxicillin, and Vonoprazan from one another. Also separated with excellent resolution were the degradation products that were formed as a result of the stress conditions. The study concluded that the developed method has considerable adoption in the pharmaceutical sector.

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“…The Ph.Eur./ BP method enables the estimation of Impurity A and Impurity C only with the runtime of about 35 mins [6,7]. Literature review provided few method for estimation of CVD along with the impurities by High-Performance Liquid Chromatography (HPLC) [8][9][10][11][12],…”

mentioning

confidence: 99%

Development and Validation of Stability-indicating High-Performance Liquid Chromatography Method for Estimation of Organic Impurities of Carvedilol from Bulk and its Dosage Form

Desai,

G. Nikalje

2023

IJPS

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The United States Pharmacopeia monograph of carvedilol states 3 different methods for evaluation of organic impurities. The present study provides a single stability-indicating analytical method for estimation of carvedilol and its organic impurities from bulk and its tablets dosage forms. The method uses Purosphere STAR RP 18-endcapped (250×4 mm, 3 µm) column and a gradient elution with a flow of 1 ml/min. Mobile phase buffer was prepared by adding 1 ml of triethylamine solution to 20 mM potassium dihydrogen phosphate solution, and pH was adjusted to 2.8±0.05 with orthphosphoric acid. Mobile phase A comprises of acetonitrile:buffer (10:1000 v/v), whereas Mobile phase B consist of methanol:acetonitrile:buffer (500:400:150 v/v/v). The eluted compounds were monitored at 226 nm and 240 nm. The column oven temperature was maintained at 50°. In the current chromatographic method total 19 impurities (3 degradation and 16 process related impurities) of carvedilol were separated in a single run. The developed method was validated as per International Council for Harmonisation guidelines for various parameters like system suitability, linearity, precision, accuracy, sensitivity (limits of detection and limits of quantification) and force degradation. All the validation parameters were within the acceptable range. The developed and validated method was quantitatively applied for estimation of all the process and degradation impurities in carvedilol active pharmaceutical ingredient and tablet formulation.

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Analytical Method Development and Validation for Known and Unknown Impurities Profiling for Carvedilol Pharmaceutical Dosage Form (Tablets)

Cited by 3 publications

References 15 publications

Simultaneous Determination of Carvedilol and its Impurities in Tablets by High Performance Liquid Chromatography

Simultaneous Determination of Carvedilol and its Impurities in Tablets by High Performance Liquid Chromatography

A Reliable Rp-Uplc-Tuv Method for Simultaneous Estimation of Clarithromycin, Amoxicillin, and Vonoprazan in Co-Packed Pharmaceutical Dosage Forms: Method Development and Validation With Stability Indicating Properties

Development and Validation of Stability-indicating High-Performance Liquid Chromatography Method for Estimation of Organic Impurities of Carvedilol from Bulk and its Dosage Form

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