Development and validation of novel uv-visible spectrophotometric method for estimation of tepotinib in bulk and in pharmaceutical formulation
By: Shirwar, Monika
.
Contributor(s): Birajdar, Shubhangi.
Publisher: Bhopal Innovare Academic Sciences Pvt Ltd 2023Edition: Vol.15(09), Sep.Description: 32-36p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
International journal of pharmacy and pharmaceutical scienceSummary: Objective: The objective of the study is to develop a new, simple, rapid, accurate, and economical UV-spectrophotometric method and validate the same for the estimation of Tepotinib in bulk and in pharmaceutical formulation as per ICH guidelines.
Methods: The present work was carried out using the UV-Visible double-beam spectrophotometer model Systronics 2201. Tepotinib was found soluble in water, methanol, methanol so, analytical-grade methanol was used as a solvent for conducting the work. The λmax of the tepotinib was determined by dissolving pure drug in methanol scanned in the range of 200-800 nm. The present method was validated for the linearity, accuracy, precision, Limit of Detection and Limit of Quantification.
Results: The maximum absorbance of tepotinib obtained at a wavelength of 272 nm. The method was found linear in the range of 3-15 µg/ml with the regression coefficient of 0.996 and the equation y = 0.0699x+0.0335. The accuracy was found to be in the range of 96.8-98.5%, the intra-day and inter-day precision % RSD value was 0.262 and 0.69, respectively and the LOD and LOQ were 0.0925 µg/ml and 0.28 µg/ml respectively.
Conclusion: The method demonstrated good reproducibility and recovery so, proposed method can be successfully applied for the routine analysis of tepotinib in bulk and pharmaceutical dosage form.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
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Articles Abstract Database
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School of Engineering & Technology Archieval Section | Not for loan | 2024-0513 |
Objective: The objective of the study is to develop a new, simple, rapid, accurate, and economical UV-spectrophotometric method and validate the same for the estimation of Tepotinib in bulk and in pharmaceutical formulation as per ICH guidelines.
Methods: The present work was carried out using the UV-Visible double-beam spectrophotometer model Systronics 2201. Tepotinib was found soluble in water, methanol, methanol so, analytical-grade methanol was used as a solvent for conducting the work. The λmax of the tepotinib was determined by dissolving pure drug in methanol scanned in the range of 200-800 nm. The present method was validated for the linearity, accuracy, precision, Limit of Detection and Limit of Quantification.
Results: The maximum absorbance of tepotinib obtained at a wavelength of 272 nm. The method was found linear in the range of 3-15 µg/ml with the regression coefficient of 0.996 and the equation y = 0.0699x+0.0335. The accuracy was found to be in the range of 96.8-98.5%, the intra-day and inter-day precision % RSD value was 0.262 and 0.69, respectively and the LOD and LOQ were 0.0925 µg/ml and 0.28 µg/ml respectively.
Conclusion: The method demonstrated good reproducibility and recovery so, proposed method can be successfully applied for the routine analysis of tepotinib in bulk and pharmaceutical dosage form.
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