Stability indicating spectrophotometric methods for quantitative determination of bromazepam and its degradation product

Darwish, Hany W.; Ali, Nesma A.; Naguib, Ibrahim A.; Ghobashy, Mohamed Mohamady; Al-Hossaini, Abdullah M.; Abdelrahman, Maha M.

doi:10.1016/j.saa.2020.118433

Cited by 11 publications

(10 citation statements)

References 48 publications

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“…However, at a lower amount than what was produced by acidic hydrolysis. The degradant was separated as mentioned before and well characterized by IR and MS spectrometry [45].…”

Section: Structure Elucidation Of Bmz Degradant (Abp)mentioning

confidence: 99%

“…� The intra-day and inter-day relative standard deviation of the average of concentrations (2, 6, 10 μg mL -1 ) of both BMZ and ABP. �� Limit of detection and quantitation were computed by calculations (LOD = 3.3×SD/slope, LOQ = 10×SD/slope) [45].…”

Section: Plos Onementioning

confidence: 99%

“…Moreover, the development of a validated stability-indicating HPLC method for BMZ quantitation in raw material and tablets is the second goal. It is worth mentioning that recently, our research team published stabilityindicating spectrophotometric methods for assaying BMZ in addaition to its degradant [45]. But the previous work was suitable only for resolving such a binary mixture of BMZ and its degradation product.…”

Section: Introductionmentioning

confidence: 99%

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Development and validation of a stability indicating RP-HPLC-DAD method for the determination of bromazepam

Darwish

Ali²,

Naguib

et al. 2021

PLoS ONE

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A reliable, selective and sensitive stability-indicating RP-HPLC assay was established for the quantitation of bromazepam (BMZ) and one of the degradant and stated potential impurities; 2-(2-amino-5-bromobenzoyl) pyridine (ABP). The assay was accomplished on a C18 column (250 mm × 4.6 mm i.d., 5 μm particle size), and utilizing methanol-water (70: 30, v/v) as the mobile phase, at a flow rate of 1.0 ml min-1. HPLC detection of elute was obtained by a photodiode array detector (DAD) which was set at 230 nm. ICH guidelines were adhered for validation of proposed method regarding specificity, sensitivity, precision, linearity, accuracy, system suitability and robustness. Calibration curves of BMZ and ABP were created in the range of 1–16 μg mL-1 with mean recovery percentage of 100.02 ± 1.245 and 99.74 ± 1.124, and detection limit of 0.20 μg mL-1 and 0.24 μg mL-1 respectively. BMZ stability was inspected under various ICH forced degradation conditions and it was found to be easily degraded in acidic and alkaline conditions. The results revealed the suitability of the described methodology for the quantitation of the impurity (ABP) in a BMZ pure sample. The determination of BMZ in pharmaceutical dosage forms was conducted with the described method and showed mean percentage recovery of 99.39 ± 1.401 and 98.72 ± 1.795 (n = 6), respectively. When comparing the described procedure to a reference HPLC method statistically, no significant differences between the two methods in regard to both accuracy and precision were found.

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“…However, at a lower amount than what was produced by acidic hydrolysis. The degradant was separated as mentioned before and well characterized by IR and MS spectrometry [45].…”

Section: Structure Elucidation Of Bmz Degradant (Abp)mentioning

confidence: 99%

Section: Plos Onementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Development and validation of a stability indicating RP-HPLC-DAD method for the determination of bromazepam

Darwish

Ali²,

Naguib

et al. 2021

PLoS ONE

Self Cite

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“…Regarding the chemical stability of BRZ, it exhibits rapid degradation following the reaction indicated in Figure 1 [ 36 ]. The main degradation product is 2-(2-amino- 5-bromobenzoyl) pyridine (ABBP), which is also considered a potential impurity commonly present in BRZ bulk form, as reported by the BP [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

A Comparative Study between Screen-Printed and Solid-Contact Electrodes for the Stability-Indicating Determination of Bromazepam

Abdel-Gawad

Altharawi

2022

Molecules

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Stability-indicating methods are awesome tools to ensure the safety and efficacy of active pharmaceutical ingredients (APIs). An accurate comparative study involving the use of potentiometric sensors for the determination of bromazepam (BRZ) in the presence of its main product of degradation and impurity was performed by the fabrication of two membrane electrodes. A screen-printed electrode (SPE) and a solid-contact glassy carbon electrode (SCE) were fabricated and their performance optimized. The fabricated sensors showed a linear electrochemical response in the concentration range 1.0 × 10−6 M to 1.0 × 10−2 M. The electrodes exhibited Nernstian slopes of 59.70 mV/decade and 58.10 mV/decade for the BRZ-SPE and BRZ-SCE membrane electrodes, respectively. The electrochemical performance was greatly affected by the medium pH. They showed an almost ideal electrochemical performance between pH 3.0 and pH 6.0. The fabricated membranes were applied successfully for the quantification of BRZ in the presence of up to 90% of its degradation product. Moreover, a successful application of the fabricated electrodes was performed for the sensitive and selective quantification of BRZ in its tablet form without any pretreatment procedure.

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“…Spectrophotometric methods are the most commonly used techniques and continue to enjoy wide popularity. These methods are more economic and simpler, compared to methods such as chromatography and electrophoresis, and can provide a very useful alternative for routine analysis of pharmaceutical formulations (11)(12)(13)(14)(15)(16)(17). For comparison, one typical liquid chromatograph generates more than 1 L of organic waste daily.…”

Section: Introductionmentioning

confidence: 99%

Validation of a green spectrophotometric method for the determination of dropropizine in commercial oral solutions

et al. 2020

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The present work describes a first-order derivative spectrophotometric (1D-UV) method for determination of dropropizine in commercial oral solutions. The method was developed using ecologically correct solvents and validated according to International Conference on Harmonization (ICH) recommendations. The response was linear in the concentration range of 6–24 μg/mL (r = 0.9997, n = 7) at wavelength 249 nm, which was the zero crossing point of excipient solutions. The detection and quantitation limits were 0.36 and 1.18 μg/mL, respectively. The method showed adequate precision, with a relative standard deviation values lower than 1.41%. Excellent values of accuracy were obtained, with a mean value of 99.44%. The method proved to be robust by a full factorial design evaluation. It is simple, it has low cost, and it has low use of polluting reagents. Minimum environmental hazards observed and the results obtained attest to the reliability of the proposed green method, showing to be specific, linear, precise, accurate and robust. Thus, the validated 1D-UV spectrophotometric method was successfully applied to the quantitative analysis of dropropizine in oral solutions dosage forms, helping to improve quality control and to assure therapeutic efficacy.

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Stability indicating spectrophotometric methods for quantitative determination of bromazepam and its degradation product

Cited by 11 publications

References 48 publications

Development and validation of a stability indicating RP-HPLC-DAD method for the determination of bromazepam

Development and validation of a stability indicating RP-HPLC-DAD method for the determination of bromazepam

A Comparative Study between Screen-Printed and Solid-Contact Electrodes for the Stability-Indicating Determination of Bromazepam

Validation of a green spectrophotometric method for the determination of dropropizine in commercial oral solutions

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