Spectrophotometric estimation of Betaxolol Hydrochloride in bulk powder and its dosage forms

Suhagia, Bhanubhai N.; Shah, Syed Muhammad Ismail; Rathod, IS; Patel, HM; Dave, Hiral N.

doi:10.4103/0250-474x.25735

Cited by 6 publications

(2 citation statements)

References 1 publication

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“…Based on the literature reports on impurity identification for ETC in human plasma by HPLC-MS/MS, 9-13 HPLC, 14 and spectrophotometric. 15 Furthermore, by using UPLC-ICP-MS, ETC was found in inflammatory arthritis patients' serum and synovial fluid. 16 Robert Hartman et al, (2003) thirteen PRIs and three major DRIs were reported, 14 and S. Venugopal et al, (2011) three PRIs and DRIs also reported in ETC.…”

Section: Introductionmentioning

confidence: 99%

LC-MS/MS Analytical Method Development and Validation for Determining Vinamidinium HexafluoroPhosphate Impurity in Etoricoxib

Ganta¹,

Rao²,

Srinivas³

et al. 2023

Ind. J. Pharm. Edu. Res.

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Background and Aim: Process impurities may adversely affect the efficacy, excellent quality, and safety of pharmaceutical drugs. Ultimately, the purpose of this research work was to develop and validate a LC-MS/MS-based method for determining the Vinamidinium hexafluorophosphate impurity (VHP) in Etoricoxib in a simple, specific, accurate, and precise manner. Materials and Methods: To elute the Vinamidinium hexafluorophosphate impurity in Etoricoxib at a flow rate of 0.5mL/min within 20.0 min of runtime, a Symmetry Shield RP18, 5µm column with a 150 x 3.9 mm internal diameter was utilized in binary gradient mode. The buffer solution, which contained formic acid (0.1%) and acetonitrile (100%), as well as a diluent solution of acetonitrile (50%) and water (50%), was used to achieve the chromatographic separation. A triple quadrupole mass spectrometer (Shimadzu LC/MS/MS 8040) in Multiple Reaction Monitoring (MRM) mode was needed to monitor the results. Results and Discussion: The method's linearity was evaluated at levels from 25% to 150%, and the R 2 value was discovered to be 0.99. Sensitivity values of 0.04µg/g (LOD) and 0.13µg/g (LOQ) were established. The recovery of impurity levels of Vinamidinium hexafluorophosphate ranges from 70.0% to 130%. Linearity, specificity, accuracy, LOD, LOQ, and precision of the method were all validated. Within the assay variability limitations, it was found that the intra-and inter-day precision values were 0.67%, and 0.58%, respectively. Conclusion: According to ICH and FDA specifications, the optimized method was validated. The developed method was found to be appropriate for quantifying Vinamidinium hexafluorophosphate in Etoricoxib by employing LC-MS.

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Section: Introductionmentioning

confidence: 99%

LC-MS/MS Analytical Method Development and Validation for Determining Vinamidinium HexafluoroPhosphate Impurity in Etoricoxib

Ganta¹,

Rao²,

Srinivas³

et al. 2023

Ind. J. Pharm. Edu. Res.

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“…Figure 1: Molecular structures of Etoricoxib spectrophotometry18 and capillary zone electrophoresis 19. HPTLC20,21 method employing a chloroform: methanol: toluene (4:2:4 v/v) mobile phase were applied to quantify ETC in the samples.…”

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confidence: 99%

A Validated Sensitive Stability Indicating HPLC Method for the Determination of Etoricoxib in Bulk and Formulation

Patil¹,

Narkhede²,

Nemade³

et al. 2023

IJPQA

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Aim: The current research aims to create a high-resolution and validated liquid chromatographic method used for quantitative detection of etoricoxib within dosage forms that is both easy to use and reliable in terms of accuracy, sensitivity, and reproducibility. Materials and Methods: Analysis was carried out at isocratic conditions at flow rate of 0.7 mL/min using a mobile phase consisting of 40 parts methanol to 60 parts water (0.1% OPA) at pH 3.2. The eluents were tested using UV detection at 236 nm. Results: Etoricoxib had clearly separated peaks with a retention duration of 4.347 minutes in the optimized settings. The concentration range used to generate the calibration curve was 10 to 60 μg/mL. LoD was 0.0779 μg/mL, and upper LoQ was 0.23 μg/mL. The approach has been effective in separating a known quantity of etoricoxib, and the percentage of degradation was shown to be very low across all stress settings. Conclusion: Etoricoxib in bulk drug and commercial formulations can be identified and quantified using the proposed method, which has been validated in accordance with ICH recommendations.

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LC and LC–MS/MS Studies for the Separation and Identification of Impurities and Degradation Products of Betaxolol

Chmangui,

Safta,

Driss

et al. 2024

Journal of Chromatographic Science

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Betaxolol (Bx) is a selective β1 receptor blocker used in the treatment of hypertension and glaucoma. The aim of the present work was to demonstrate an approach involving use of liquid chromatography (LC) and liquid chromatography-electrospray ionization mass spectrometry (LC-ESI/MS) for the simultaneous separation, identification and characterization of impurities and of degradation products of betaxolol without their isolation from the reaction mixtures. At optimum condition, and according to ICH guidelines, the limit of detection (LOD) and limit of quantification (LOQ) for Bx are found to be 5.46 and 16.54 μg mL−1, respectively. However, the LOD and LOQ for the major degradation product P6 were 2.15 and 6.53 μg mL−1. Betaxolol was subjected to hydrolytic (acidic and basic) and oxidative, stress conditions according to International Conference on Harmonization (ICH) guideline Q1A (R2), and as results, the drug was found to be labile in acidic, basic and oxidative stress conditions. Based on LC-ESI/MS analysis, the found results revealed that Bx decomposes in acidic, basic and oxidizing environments. All degradation products were identified with the help of their fragmentation pattern and the masses obtained upon the MS analysis.

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Spectrophotometric estimation of Betaxolol Hydrochloride in bulk powder and its dosage forms

Cited by 6 publications

References 1 publication

LC-MS/MS Analytical Method Development and Validation for Determining Vinamidinium HexafluoroPhosphate Impurity in Etoricoxib

LC-MS/MS Analytical Method Development and Validation for Determining Vinamidinium HexafluoroPhosphate Impurity in Etoricoxib

A Validated Sensitive Stability Indicating HPLC Method for the Determination of Etoricoxib in Bulk and Formulation

LC and LC–MS/MS Studies for the Separation and Identification of Impurities and Degradation Products of Betaxolol

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