Development and validation of a dissolution test with reversed-phase high performance liquid chromatographic analysis for Candesartan cilexetil in tablet dosage forms

Kamalakkannan, V.; Puratchikody, Ayarivan; Ramanathan, Lakshmanan; Jayapraba, S.

doi:10.1016/j.arabjc.2011.09.011

Cited by 6 publications

(4 citation statements)

References 5 publications

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“…System suitability is an important parameter which allows to ensure that the resolution and reproducibility of the chromatographic system are adequate for the analysis and whether the used method is valid or not 3 , 13 . %RSD for peak areas of six consecutive injections of SSS solution was found to be ≤ 2.0% (0.2% for SA and ASA) (Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product

Kowalska

Woźniak

Kijek³

et al. 2022

Sci Rep

1,842

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The work mainly focused on a validation of the method for determining the content of salicylic acid and individual unknown impurities in new pharmaceutical product—tablets containing: 75, 100 or 150 mg of acetylsalicylic acid and glycine in the amount of 40 mg for each dosage. The separation of the components was carried out by means of HPLC, using a Waters Symmetry C18 column (4.6 × 250 mm, 5 μm) as the stationary phase. The mobile phase consisted of a mixture of 85% orthophosphoric acid, acetonitrile and purified water (2:400:600 V/V/V). Detection was carried out at a wavelength of 237 nm, with a constant flow rate of 1.0 ml min−1. In order to verify the method, linearity, precision (repeatability and reproducibility), accuracy, specificity, range, robustness, system precision, stability of the test and standard solution, limit of quantification and forced degradation were determined. Validation tests were performed in accordance with ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines. The method was validated successfully. It was confirmed that the method in a tested range of 0.005–0.40% salicylic acid with respect to acetylsalicylic acid content is linear, precise and accurate.

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Section: Resultsmentioning

confidence: 99%

Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product

Kowalska

Woźniak

Kijek³

et al. 2022

Sci Rep

1,842

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“…The drug release of FDT-1 and FDT-2 was similar (f 2 >50) in both media, which may be due to the similar formulation parameters in both tablets. 8,20 Confirmation of discriminating dissolution test conditions Different dissolution profiles were obtained for FDTs of varying nature ( Figures 5 and 6). In the present study dissimilarity in drug release was observed with DOM-1 compared to DOM-2 in 0.5% SLS (f 2 =26) and similarity in drug release was observed with 0.1 N HCl (f 2 =58).…”

Section: Optimization Of Dissolution Test Conditionsmentioning

confidence: 76%

Development and Validation of <i>In Vitro</i> Discriminatory Dissolution Testing Method for Fast Dispersible Tablets of BCS Class II Drug

Bhatt

Roy

Kumar

et al. 2020

tjps

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ÖZAmaç: Hızlı dağılabilir tabletler (FDT'ler), çok hızlı dağıldıkları için in vitro etken madde salımının ayrımı ve değerlendirilmesi zordur. Bu nedenle, bu çalışmada, BCS sınıf II domperidonun FDT'leri için yeni bir in vitro ayırt edici çözünme yöntemi geliştirilmiş ve valide edilmiştir. Gereç ve Yöntemler: Domperidonun FDT'leri direkt basım yöntemi ile hazırlanmıştır. Çözünme çalışmaları sekiz istasyonlu Electrolab TDT-082 çözünme test cihazında gerçekleştirilmiştir, ultraviyole spektrofotometre ile analiz edilmiş ve taze distile su ile sodyum lauril sülfat (%0,5, % 1,0 ve %1,5), simüle bağırsak sıvısı pH 6,8 ile simüle enzimsiz mide sıvısı pH 1,2, fosfat tampon çözeltisi (pH 6,8) ve 0,1N hidroklorik asit gibi farklı çözünme ortamlarında farklı çalkalama hızlarında değerlendirilmiştir. Bulgular: Geliştirilen yöntem özgüllük, doğruluk, kesinlik, doğrusallık ve sağlamlık açısından doğrulanmıştır. Farklı ortamlar arasında, distile su ile %0,5 sodyum lauril sülfat (SLS)'nin daha yüksek ayrım gücü ile optimum olduğu bulunmuştur. Geri kazanım yüzdesi %96 ila %100,12 ve kesinlik için bağıl standart sapma değerinin (gün içi ve günler arası) %1'den az olduğu bulunmuştur. Ayrıca hazırlanan FDT'lerin %0,5 SLS içeren distile sudaki çözünme profili, salım profilinde farklılığı gösteren ve geliştirilen yöntemin ayırt edici doğasını doğrulayan benzerlik (f2) ve fark (f1) faktörü hesaplaması kullanılarak karşılaştırılmıştır. Sonuç: FDT'ler için ayırt edici çözünme yöntemi geliştirilmiş ve valide edilmiştir. Elde edilen tüm sonuçlar tatmin edici, doğru ve aralık içindedir. Mevcut yöntem, formülasyon geliştirilmesi ve FDT'lerin kalitesinin değerlendirilmesi için faydalı olabilir. Anahtar kelimeler: Validasyon, ayırt edici çözünme yöntemi, hızlı dağılabilir tabletler (FDT'ler), domperidon ABSTRACT Objectives: Fast dispersible tablets (FDTs) get dispersed very fast due to which the discrimination of in vitro drug release and their evaluation is difficult. Hence in the present study a new in vitro discriminatory dissolution method was developed and validated for FDTs of domperidone of BCS class II. Materials and Methods: FDTs of domperidone were prepared by direct compression method. The dissolution studies were performed in an eightstation Electrolab TDT-082 dissolution testing apparatus, analyzed by ultraviolet spectrophotometer and evaluated in different dissolution mediums i.e. sodium lauryl sulphate (0.5%, 1.0% and 1.5%) with fresh distilled water, simulated intestinal fluid pH 6.8, simulated gastric fluid pH 1.2 without enzymes, phosphate buffer solution (pH 6.8) and 0.1 N hydrochloric acid at different agitation speeds. Results: The developed method was validated in terms of specificity, accuracy, precision, linearity and robustness. Amongst the different mediums, 0.5% sodium lauryl sulfate (SLS) with distilled water was found to be optimum with higher rate of discriminatory power. The percentage recovery was found to be 96 to 100.12 % and the % relative standard deviation value for precision (intraday and interday) was foun...

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“…A dissolution method is discriminative when it is able to assert significant changes in the formulations and manufacturing processes of the tested drugs that may affect the performance of the formulation (31). The method using 0.1 M HCl with addition of 1.0% SDS, paddle conditions at 100 rpm, presented higher ED and was discriminative for the two formulations developed.…”

Section: In Vitro Drug Releasementioning

confidence: 99%

Fipronil Tablets: Development and Pharmacokinetic Profile in Beagle Dogs

et al. 2019

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Increased human-pet interactions have led to concerns related to the prevention and treatment of ectoparasite infestations. Fipronil (FIP) is a widely used ectoparasiticide in veterinary medicine available for topical administration; however, its use may cause damage to the owners and the environment. The aim of the study was to develop immediate-release tablets of FIP, as well as to determine its pharmacokinetic properties after oral administration in beagle dogs. The prepared FIP tablets were evaluated for precompression (angle of repose, speed flow, and Carr's index) and post-compression (weight variation, friability, thickness, hardness, disintegration time, and dissolution rate) parameters. Orally administered FIP at a dose of 2 mg/kg was rapidly absorbed with C máx of 3.13 ± 1.39 μg/mL at 1.83 ± 0.40 h post treatment (P.T.) and metabolized with 1.27 ± 1.04 μg/mL at 2.33 ± 0.82 h P.T. for fipronil sulfone (SULF) (the primary metabolite). The elimination of FIP and SULF occurred slowly and had maintained quantifiable plasma levels in the blood for up to 28 days P.T. The goal of the study is aligned with the concept of One Health, which aims to collaboratively achieve the best health for people, animals, and the environment. Therefore, the use of FIP tablets for the control of ectoparasites in dogs may be a safer alternative for owners and the environment.

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Development and validation of a dissolution test with reversed-phase high performance liquid chromatographic analysis for Candesartan cilexetil in tablet dosage forms

Cited by 6 publications

References 5 publications

Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product

Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product

Development and Validation of <i>In Vitro</i> Discriminatory Dissolution Testing Method for Fast Dispersible Tablets of BCS Class II Drug

Fipronil Tablets: Development and Pharmacokinetic Profile in Beagle Dogs

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