Application of HPLC to assess the compatibility of bisoprolol fumarate with selected excipients in mixtures by isothermal stress testing

Marothu, Vamsi Krishna; Yerramothu, P.; Gorrepati, Madhavi; Majeti, S.; Mamidala, S.K.; Nellutla, A.

doi:10.1016/j.pharma.2015.05.001

Cited by 9 publications

(3 citation statements)

References 41 publications

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“…73 Najčešće primjenjivane tehnike analize uzoraka nakon IST-a su kromatografske tehnike poput tekućinske kromatografije visoke djelotvornosti i/ili spektroskopske tehnike poput FTIR-a. 73,74,89,[104][105][106][107] Izotermalne studije razgradnje provedene su na čistim sastavnicama sulfasalazina, mesalazina i folne kiseline te na smjesama standarda i gotovih dozirnih oblika pripremljenim u omjeru u kojem se očekuje da će sastavnice biti u gotovom proizvodu (500 : 1). Svi uzorci su vizualno pregledani prije i nakon skladištenja u izotermalnim uvjetima da bi se uočile potencijalne promjene u samom izgledu uzoraka.…”

Section: Studije Izotermalne Razgradnjeunclassified

Ispitivanje fizikalno-kemijske kompatibilnosti lijekova primjenom analitičkih tehnika: pregled istraživanja razvoja fiksne kombinacije 5-aminosalicilata i folne kiseline

Jeličić

2022

Kemija U Industriji

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With the use of fixed-dose drug combinations, the potential risk of non-adherence needs to be minimised, which is particularly important in patients with chronic diseases. The development of such dosage form is a complex process in which an important role is played by testing the physicochemical compatibility of the components intended for the manufacture of the desired product. Various analytical techniques, such as thermoanalytical (DSC, DTA), spectroscopic (FTIR, XRPD) and chromatographic (HPLC), in combination with certain degradation studies, such as forced degradation and isothermal degradation, are often used. In this review, on the example of the development of a fixed-dose combination of 5-aminosalicylate and folic acid, procedures suitable for testing the compatibility of drug components, as well as analytical techniques and various ways of interpretation of results are described.

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Section: Studije Izotermalne Razgradnjeunclassified

Ispitivanje fizikalno-kemijske kompatibilnosti lijekova primjenom analitičkih tehnika: pregled istraživanja razvoja fiksne kombinacije 5-aminosalicilata i folne kiseline

Jeličić

2022

Kemija U Industriji

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“…Several analytical techniques were available for the determination of the BF drug. These techniques include: spectroscopic techniques [3–10], chromatographic techniques [11–18], cyclic voltammetric and square wave voltammetric techniques (SWV) [19]. Most of these techniques are very expensive, require sample pre‐treatment, and required large quantities of not environmentally friendly organic solvents [20, 21].…”

Section: Introductionmentioning

confidence: 99%

A Novel Molecularly Imprinted Potentiometric Sensor for the Fast Determination of Bisoprolol Fumarate in Biological Samples

et al. 2020

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In this study, molecularly imprinted polymer (MIP) was prepared and used in the preparation of carbon paste electrode (CPE) for the quantification of bisoprolol fumarate (BF) in pure, pharmaceutical formulation and biological fluids. The selective MIP for BF was synthesized from methacrylic acid as the functional monomer, ethylene glycol dimethacrylate as the cross‐linker in dimethyl sulfoxide solution, BF as the template molecule and 2, 2‐azobisisobutyronitrile (AIBN) as the initiator. The non‐imprinted polymer (NIP) was synthesized by the same procedure, but in the absence of the template molecule then incorporated in the paste of the carbon paste electrodes (CPEs). The prepared MIP for BF and its corresponding NIP were well characterized using scanning electron microscopy (SEM), Fourier transform infrared spectrometer, and thermal gravimetric analysis (TGA). The MIP and NIP based CPEs were further used for the determination of BF and the obtained results indicated that the sensor modified by the MIP have much higher recognition power for the BF molecules than the NIP based sensor where the MIP based CPE exhibited a Nernstian response 29.50±0.55 mV decade−1 within a concentration range of 1.0×10−7–1.0×10−2 mol L−1and pH independence in the range 3.50–7.15. The proposed sensor has high selectivity over several possible interfering compounds. The obtained results by the proposed sensor were satisfactory with excellent percentage recovery and relative standard deviation and were comparable with those obtained from HPLC reported method.

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“…Additionally, Petrit et al reported bisoprolol reactivity to hydrolytic degradation at different pH conditions, Ghauch et al and Prachi et al reported bisoprolol sensitivity to oxidative degradation conditions, Marothu et al reported isothermal stress testing of bisoprolol fumarate. [3][4][5][6] In literature, Pandey et al reported thermal degradation of bisoprolol in stability indicating method. 7 Combination of bisoprolol with other drugs are used in hypertension treatment.…”

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confidence: 99%

Characterization of Degradation Products of Bisoprolol by LC-MS and In-silico Determination of Toxicity and Biological Activity Prediction of its Degradation Product: A Comprehensive Approach during Drug Development

Chandramore,

Sonawane

2023

IJPQA

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The stability of bisoprolol in tablet and bulk form was developed and validated using chromatographic methods. The bisoprolol was exposed to oxidizing agents like hydrogen peroxide, heat (dry and wet) and photolytic conditions, acid, alkali, and water hydrolysis. However, considerable degradation was observed in acid, alkali, oxidative, and wet heat thermal conditions. The drug’s stability under photolytic and dry heat conditions was established. The drug and its degradation products were separated on ODS C-18 with the specification of (250 mm × 4.6 mm, 5 μm) and the mobile phase containing acetonitrile and phosphate buffer (20 mM, pH 8) (60:40, v/v). According to ICH Q2 (R1) all method validation parameters are verified. Determination of the active pharmaceutical ingredient was not interfered by excipients or degradation products. In the 6–14 μg/mL range, the response was shown to be linear. One degradation product’s LC-MS m/z values and fragmentation patterns matched an impurity mentioned in the drug’s European Pharmacopoeia monograph. The remaining three were unidentified degradation products. LC-MS fragmentation experiments were used to characterize the products. The findings may lead to the suggestion of a more thorough drug degradation mechanism. The Toxtree software (Version 3.1.1) was then used to forecast the toxicity of the degradation products. Additional toxicity determination was carried out by using in-silico method.

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Application of HPLC to assess the compatibility of bisoprolol fumarate with selected excipients in mixtures by isothermal stress testing

Cited by 9 publications

References 41 publications

Ispitivanje fizikalno-kemijske kompatibilnosti lijekova primjenom analitičkih tehnika: pregled istraživanja razvoja fiksne kombinacije 5-aminosalicilata i folne kiseline

Ispitivanje fizikalno-kemijske kompatibilnosti lijekova primjenom analitičkih tehnika: pregled istraživanja razvoja fiksne kombinacije 5-aminosalicilata i folne kiseline

A Novel Molecularly Imprinted Potentiometric Sensor for the Fast Determination of Bisoprolol Fumarate in Biological Samples

Characterization of Degradation Products of Bisoprolol by LC-MS and In-silico Determination of Toxicity and Biological Activity Prediction of its Degradation Product: A Comprehensive Approach during Drug Development

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