High-performance liquid chromatographic separation and determination of the process related impurities of mebendazole, fenbendazole and albendazole in bulk drugs

Gomes, Antony Raj; Nagaraju, V.

doi:10.1016/s0731-7085(01)00446-0

Cited by 32 publications

(20 citation statements)

References 15 publications

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“…The most common drugs used as anthelmintics belong to the benzimidazole series of which the most commercialized in the world are: Albendazole (ALB), Fenbendazole (FEN) and Mebendazole (MEB) [5][6][7][8][9][10][11][12] (Fig. 1).…”

Section: -4)mentioning

confidence: 99%

Photo- and Thermal-Stability Studies on Benzimidazole Anthelmintics by HPLC and GC-MS

Ragno

Risoli

Ioele

et al. 2006

CHEMICAL & PHARMACEUTICAL BULLETIN

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Infections by worms represent a serious health problem in the tropical and subtropical regions, when the environmental conditions are especially critical for the drug storage, due to both high temperature and strong sunlight. Under these stressing climatic conditions, the characterization of the thermal-and photo-stability of drugs and drug formulations is of high interest. Light and high temperature can influence a drug formulation, leading to changes in the physico-chemical and therapeutic properties of the active principles. 1-4)The most common drugs used as anthelmintics belong to the benzimidazole series of which the most commercialized in the world are: Albendazole (ALB), Fenbendazole (FEN) and Mebendazole (MEB) [5][6][7][8][9][10][11][12] (Fig. 1). Benzimidazole drugs inhibit in an irreversible way the glucose uptake leading to the depletion of glycogen storage of the parasites. 13,14) Due to their chemical features, all the benzimidazole drugs are sensitive to light, with a behaviour common to all members of this class of compounds. 13,15) The amine derivative from hydrolysis of the carbamic group has been reported to be the main photodegradation product, indicated also by metabolism studies as the major metabolite of the drugs.13) Accordingly, a close monitoring of these drugs, as such or in pharmaceutical formulations, constitutes a noteworthy analytical problem in regions presenting tropical climate. HPLC procedures have been used for determination of MEB, 15) ALB 16,17) and FEN 17) in veterinary formulations whereas only a TLC method for the degradation study of MEB is reported. 11)In the present paper, the studied drugs were exposed to various conditions of stressing light and temperature. The degradation study was performed under controlled conditions, using a cabinet provided with a Xenon lamp, able to simulate the solar light spectrum, and a temperature controller.The photoproducts were monitored by HPLC and characterized by GC-MS. HPLC method was validated by analysis of synthetic mixtures containing different amounts of drugs and photoproducts. HPLC method was finally applied to the analytical control of the drugs commercial formulations. Results and DiscussionPhoto-Degradation Study Ethanol solutions of ALB, FEN and MEB (20 mg/ml) were exposed to controlled irradiation and analyzed at time intervals up to 10 h. Figure 2 shows semi-logarithmic plots of the % residue drug vs. irradiation time. The concentration of the products were obtained as a function of the respective peak areas carried out by HPLC chromatography. The drugs concentration values were carried out by using the relationships reported in Table 1. The exposure to light of the drugs in ethanol solution caused a marked degradation for all the compounds. Figure 3 shows the chromatograms of the ethanol solutions Photo-and thermal-stability of the anthelmintics Albendazole, Mebendazole and Fenbendazole as in solid as in solution form has been investigated, by using a Xenon arc lamp as a radiation source, according to the ICH guideline...

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Section: -4)mentioning

confidence: 99%

Photo- and Thermal-Stability Studies on Benzimidazole Anthelmintics by HPLC and GC-MS

Ragno

Risoli

Ioele

et al. 2006

CHEMICAL & PHARMACEUTICAL BULLETIN

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“…11 Moreover, it has been determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) in environmental samples, 12 in eggs using capillary electrophoresis-mass spectrometry (CE-MS), 13 in surface water using ultra-high performance liquid chromatography coupled to quadrupole linear ion trap mass spectrometry (UHPLC-QqLIT-MS), 14 in swine tissues by ultra-high performance liquid chromatography time-of-flight mass spectrometry (UHPLC-TOF/MS) 15 and in chicken by UHPLC-MS/MS. 16 An LC-Orbitrap-HRMS was used for the determination of some anthelmintic drug residues (including fenbendazole) in distillers grains.…”

Section: Introductionmentioning

confidence: 99%

“…16 An LC-Orbitrap-HRMS was used for the determination of some anthelmintic drug residues (including fenbendazole) in distillers grains. 17 Praziquantel has been determined by LC-MS/MS, 9,10 HPLC, 11 cathodic adsorptive stripping differential-pulse voltammetry, 13 UPLC-MS 14 methods in milk and human plasma.…”

Section: Introductionmentioning

confidence: 99%

Development of a Dissolution Test for Fenbendazole-Praziquantel Capsules Using UV-PLS Method

Vignaduzzo¹,

Operto²,

Castellano³

2016

J. Braz. Chem. Soc.

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A dissolution test for capsules containing 50 mg of praziquantel and 500 mg of fenbendazole was developed and validated. The optimal conditions were an USP apparatus 2 with paddles rotating at 75 rpm, 900 mL dissolution medium (a mixture of 300 mL of ethanol and 600 mL 0.5 mol L -1 HCl), at 37.0 ± 0.5 °C. Both analytes achieved with sink conditions. A published highperformance liquid chromatography (HPLC) method was used to monitoring dissolution test during the optimization. Additionally, a chemometrics method based on UV-VIS spectrophotometry and partial least-squares (PLS) was developed and validated for the simultaneous determination of both analytes in the dissolution media. The coefficients of determination were 0.9986 and 0.9959 for fenbendazole and praziquantel, respectively, and the elliptical joint confidence region (EJRC) test concluded that constant and proportional biases were absent. The optimized model was applied to build dissolution profile and its results did not show statistical differences with HPLC method.

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“…For the evaluation of pyrantel pamoate in binary mixture with oxantel pamoate, ACN with butylamine modifier mobile phase and C8 reversed phase column were used (11). Oxfendazole-oxyclozanide (2) binary mixture and combined preparations of similar antihelmintic drugs as mebendazole, fenbendazole, albendazole and their related impurities were determined together (23). Nonetheless the absence of a report on determination of pyrantel pamoate, oxantel pamoate and praziquantel mixture from biological fluids or pharmaceutical dosage forms simultaneously, directs us to emphasize determination of these drugs.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a RP-HPLC method for quality control of oxantel pamoate, pyrantel pamoat and praziquantel in tablets

Tatar¹,

Ates²,

Küçükgüzel

2015

mpj

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In the present study, simple, rapid and precise HPLC methods were developed which would be useful for quality control of pharmaceutical dosage forms containing praziquantel (PRZ), pyrantel pamoate (PPA) and oxantel pamoate (OPA). The first method (M 1 ) was developed for the analysis of PRZ; separation was achieved using a reversed-phase column (4.6 x 150 mm, 5 µm) C18, a mobile phase comprising ACN:MeOH:20 mM phosphate buffer (0.2 % TEA, pH 4.5) (50:10:40, v/v/v) and UV detection at 210 nm. PPA and OPA were analysed simultaneously using a separate method (M 2 ) by employing the same column and flow rate. In accordance with the second method (M 2 ), detection wavelength was set at 295 nm and a mobile phase of ACN:MeOH:20 mM phosphate buffer (0.2 % TEA, pH 4.5) (12:3:85, v/v/v) was used. Benazepril hydrochloride (BZP) and paracetamol (PAR) were used as internal standards (IS) of the methods M 1 and M 2 , respectively. Both methods were validated based on the parameters such as specifity, linearity, precision, accuracy, limit of detection (LOD) and limit of quantitation (LOQ) besides system suitability tests. Forced degradation studies were performed to indicate specifity of the proposed methods. The methods were found linear over the concentration ranges of 0.5-7.5 µg/mL, 1-15 µg/mL and 2-40 µg/mL for PRZ, PPA and OPA, respectively. Correlation coefficients (r) of the regression equations were greater than 0.999 in all cases. The precision of the methods was demonstrated using intra-and inter-day assay RSD values which were less than 1% in all instances. Accuracy of the proposed methods was tested on placebo tablets spiked with known amounts of actives. Resulting recoveries of assays were in the range of 99.9-101.1 % whereas, those from commercial tablets were 99.4-100.8 %.

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High-performance liquid chromatographic separation and determination of the process related impurities of mebendazole, fenbendazole and albendazole in bulk drugs

Cited by 32 publications

References 15 publications

Photo- and Thermal-Stability Studies on Benzimidazole Anthelmintics by HPLC and GC-MS

Photo- and Thermal-Stability Studies on Benzimidazole Anthelmintics by HPLC and GC-MS

Development of a Dissolution Test for Fenbendazole-Praziquantel Capsules Using UV-PLS Method

Development and validation of a RP-HPLC method for quality control of oxantel pamoate, pyrantel pamoat and praziquantel in tablets

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