A Stability Indicating Method was Developed and Validation for the Estimation of Carbamazepine in Bulk and Tablet Dosage form by UV-Spectroscopic Techniques

Ghosh, Manmohan; Mondal, Sambhu Charan; Chakraborty, Subhadip; Ghosh, Nikita

doi:10.22270/jddt.v13i3.5987

Cited by 3 publications

(2 citation statements)

References 16 publications

(17 reference statements)

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“…The designed and validated approach was linear, accurate, precise, and robust against the wide concentration of ritonavir, which might help qualitative and quantitative validation. The significant objective of this study was to pinpoint the spectroscopic and chromatographic techniques that were reliable enough to produce an appropriate separation of the components with a good spectrum for the UV-spectroscopic method and chromatogram within a reasonable run time for the high-performance liquid chromatographic method [29][30][31]. The target analytical profile was created to identify critical method attributes influencing critical quality attributes, and a systematic risk analysis was conducted.…”

Section: Discussionmentioning

confidence: 99%

A New Robust Analytical Method Development, Validation, and Stress Degradation Studies for Estimating Ritonavir by Uv-Spectroscopy and HPLC Methods

PARVEEN,

ROUTH,

GOSWAMI

et al. 2023

Int J App Pharm

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Objective: To specify ritonavir and its commercial dosage form, the current study set out to design and validate concise, precise, and efficient high-performance liquid chromatography and spectrophotometric methods. The developed spectroscopy and chromatographic methods are reliable, precise, accurate, and specific for estimating ritonavir. Methods: The method is superior to previously described methods due to its shorter retention duration, use of an affordable and easily accessible mobile phase, UV detection, and improved peak resolution. The maximum absorbance was determined by analysing multiple concentration ranges of ritonavir at 10-60 µg/ml using the UV-spectrophotometric method. The chromatographic separation was performed with a mobile phase composed of acetonitrile and 0.1% formic acid (1:1 v/v) pumped at a 1.0 ml/min flow rate on a phenyl (150 x 4.6 mm, 3.5 µm) column. Results: Obeyed Beer-Lambert law over the 10-60 µg/ml and 25-150 µg/ml concentration range of ritonavir for the UV-spectrophotometric and HPLC methods, respectively. The absorbance at 273 nm was selected as the maximum absorbance throughout the UV-spectroscopic study. The detection and quantification limits for UV-spectroscopic are 0.89 and 2.93 µg/ml, whereas for the HPLC method are 0.78 and 2.57 µg/ml, respectively. In the accuracy and precision validation studies, the amount of recovery and percentage of RSD was excellent with acceptance limits as per International Conference on Harmonization (ICH) guidelines. Conclusion: The suggested method has been approved following standards established by the ICH. The developed methods can be employed to analyse ritonavir API and pharmaceutical dosage forms and provide better specificity, excellent separation, and specified analyte and degradation substances.

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Section: Discussionmentioning

confidence: 99%

A New Robust Analytical Method Development, Validation, and Stress Degradation Studies for Estimating Ritonavir by Uv-Spectroscopy and HPLC Methods

PARVEEN,

ROUTH,

GOSWAMI

et al. 2023

Int J App Pharm

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“…Drug at a concentration of 1mg ml -1 was used in all degradation studies. Conditions employed for stability studies were as follows [20][21][22] .…”

Section: Forced Degradation Studiesmentioning

confidence: 99%

Development and Validation of Stability Indicating Assay Method of Doxycycline Hyclate by using UV-Spectrophotometer

Sahoo¹,

Sahoo²,

Mohapatra³

et al. 2023

J. Drug Delivery Ther.

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In the present study a simple, rapid, sensitive, and cost-effective stability indicating UV- spectrophotometric method was developed of doxycycline hyclate in bulk form and validated as per ICH guidelines. The stability-indicating study of doxycycline hyclate was based on the forced degradation reactions of the drug under different ICH-prescribed stress conditions like acid, alkali, neutral, oxidation, thermal, and photolysis. The absorption maximum of the drug was shown at 270nm and methanol was selected as solvent on the basis of the solubility of the drug. A linear relation with a regression coefficient value (R2) of 0.999 indicates that the method follows Beer’s- Lambert’s law within the concentrations range of 5 - 50µg/ml. The detection limit and quantitation limit were found to be 0.53 µg/ml and 1.55 µg/ml respectively. The % of recoveries was found to be within the range of 98.87 -99.88 with a low % of RSD indicating the accuracy of the method for estimation of the drug. Under stressed conditions, significant degradation was found in alkali, neutral and oxidation conditions and found to be sensitive under thermal and photolytic conditions but stable to acidic hydrolytic conditions. The developed method was validated according to ICH guidelines and found accurate, precise, and specific, suggesting that the developed stability-indicating spectroscopic method could be successfully adopted to estimate doxycycline hyclate. Keywords: Doxycycline Hyclate; Stability Indicating method; UV spectrophotometer; Validation; Stress degradation.

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Safety and efficacy of carbamazepine in the treatment of trigeminal neuralgia: A metanalysis in biomedicine

Guo,

Shen,

Zhou

et al. 2024

MBE

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<abstract> <p>Trigeminal neuralgia is a debilitating condition characterized by severe facial pain. Carbamazepine has been widely used as a first-line treatment option for trigeminal neuralgia, but there is a need to evaluate its safety and efficacy based on existing evidence. This meta-analysis aims to systematically assess the available literature and provide a comprehensive evaluation of the safety and efficacy of carbamazepine in the treatment of trigeminal neuralgia. A thorough search of electronic databases yielded a total of 15 relevant studies that met the inclusion criteria. The pooled analysis of these studies revealed that carbamazepine demonstrated significant efficacy in reducing pain intensity and frequency in patients with trigeminal neuralgia. Moreover, the drug was generally well-tolerated, with the most common adverse events being mild and transient. Subgroup analyses based on different dosages and treatment durations further supported the overall findings. However, caution should be exercised in patients with certain comorbidities or specific populations, as some rare but severe adverse events were reported. In conclusion, this meta-analysis provides strong evidence supporting the safety and efficacy of carbamazepine as a valuable therapeutic option for the management of trigeminal neuralgia. These results can guide clinicians in making informed decisions regarding the use of carbamazepine and contribute to optimizing treatment strategies for patients with trigeminal neuralgia. Further research is warranted to explore long-term safety and efficacy outcomes, as well as to compare carbamazepine with alternative treatment modalities.</p> </abstract>

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A Stability Indicating Method was Developed and Validation for the Estimation of Carbamazepine in Bulk and Tablet Dosage form by UV-Spectroscopic Techniques

Cited by 3 publications

References 16 publications

A New Robust Analytical Method Development, Validation, and Stress Degradation Studies for Estimating Ritonavir by Uv-Spectroscopy and HPLC Methods

A New Robust Analytical Method Development, Validation, and Stress Degradation Studies for Estimating Ritonavir by Uv-Spectroscopy and HPLC Methods

Development and Validation of Stability Indicating Assay Method of Doxycycline Hyclate by using UV-Spectrophotometer

Safety and efficacy of carbamazepine in the treatment of trigeminal neuralgia: A metanalysis in biomedicine

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