UV Spectrophotometric Method Development and Validation of Dasatinib in Bulk and Formulation

Author(s):  
Jyoti Mittha ◽  
Bhavana Habib

UV-Spectrophotometric method has been developed and validated for quantitative estimation of dasatinib in bulk and pharmaceutical formulation. Dasatinib is soluble in acetonitrile, so it was used as solvent. Dasatinib was dissolved in acetonitrile and resulting solution was scanned in UV range (200-400nm). The λmax was found to be 315nm. Beers law is valid in concentration range of 5-25µg/ml. The developed method was validated for linearity, accuracy, precision, robustness; LOD and LOQ. Linearity was obtained in the range of 5-25µg/ml with correlation coefficient 0.9992. LOD and LOQ were found to be 0.908µg/ml and 2.752µg/ml respectively. The method showed good reproducibility and recovery so; proposed method can be applied for routine analysis of dasatinib in bulk and pharmaceutical formulation.

Author(s):  
A.C. Bhosale ◽  
V.C. Bhagat ◽  
V. V Kunjir ◽  
D.P. Kardile ◽  
R.V. Shete

Purpose: Analytical method development and validation for the quantitative determination of Prucalopride succinate in bulk and tablet formulation which plays major role in the development and manufacture of pharmaceuticals. Methods: In the present work a simple, rapid and reproducible UV-Visible Spectrophotometric method was developed and validated according to ICH guidelines. Results and Conclusions: The parameters linearity, specificity, precision, accuracy, and robustness were studied. The wavelength 243nm was selected for the estimation of drug using methanol as a solvent. The drug obeys Beer-lambert’s law over the concentration range 2-10μg/ml. The accuracy of the method was assessed by recovery studies and was found between 97.2- 98.3 %. The method was successfully applied for routine analysis of Prucalopride succinate in bulk and formulation.


Author(s):  
Suvarna Y ◽  
Madhavi A.

The present work describes the development of accurate, precise and high economic value for the simultaneous estimation of Cefpodoxime proxetil and Dicloxacillin sodium by hydrotropy method using UV spectroscopy was developed and validated. The method was performed on Lab c, model UV-3000 spectrophotometer with UV win software. 1M urea was used as a solvent for analysis. Detection was carried out at 230nm for Cefpodoxime proxetil and 210 nm for Dicloxacillin sodium. Linearity was observed at concentration range 2-20 µg/ml for Cefpodoxime proxetil and 5-30 µg/ml for Dicloxacillin sodium. Correlation coefficient for Cefpodoxime proxetil and Dicloxacillin sodium was found to be 0.993 and 0.9998 respectively. The method can be successfully applicable to routine analysis.


Author(s):  
BHAGYASHRI S. SHINDE ◽  
M. S. KALSHETTI ◽  
ANJALI P. KOKANE

Objective: A new sensitive, economical, simple, rapid UV spectrophotometric method has been developed for the estimation of Saxagliptin in API and pharmaceutical formulation. Methods: Calibration curve method was used for the estimation of Saxagliptin in API and pharmaceutical formulation. Results: The method was validated for linearity, range, accuracy, precision, robustness, LOD, LOQ. Linearity was found in the range of 10-60µg/ml. Accuracy was performed by using a recovery study. The amount of drug recovered was found to be in the range of 99.01-100.1%. All the parameters were validated as per the ICH guidelines. Conclusion: This method is suitable forused routine analysis of present Saxagliptin in API and Pharmaceutical dosage form.


Author(s):  
Roshani Singh ◽  
Omray L K ◽  
Pushpendra Soni

In this article “new cost-effective RP-HPLC method development and validation for quantitative estimation of ivacaftor in the pharmaceutical formulation” developed. This study includes RP-HPLC Spectrophotometric method development, such as economical and simple HPLC method was optimized during development and validated accordingly in tablets of ivacaftor. The developed method may utilize for the analysis of ivacaftor at the laboratory level. The result shows that developed methods are cost-effective, rapid (Short retention time), simple, accurate (the value and %RSD between 2-5), precise, and can be used for the intended purpose on the tablet dosage form. The present proposed method is capable of better separation of analyte and qualifies on the point of analytical validation such as linearity, specificity, accuracy, precision, robustness, LOD, and LOQ on a marketed formulation. The simplicity, rapidity, and reproducibility of the developed method qualify the objective of the research. Results of analysis of the ivacaftor tablet formulations are arranged in the experimental, result, and discussion section. The portion of ivacaftor found in terms of quantity was between 98-102% and also within USP 29 chapter (541) acceptance criteria.


Author(s):  
SMITA KUMBHAR ◽  
VINOD MATOLE ◽  
YOGESH THORAT ◽  
ANITA SHEGAONKAR ◽  
AVINASH HOSMANI

Objective: A new, simple, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the determination of Imatinib in pharmaceutical formulations with alizarin. Methods: The method is based on formation of yellow-colored complex. The UV spectrum of Imatinib in methanol showed λ max at 431 nm. Beer’s law is valid in the concentration range of 10-70 μg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-70 μg/ml with regression equation y =0.013x-0.017 and regression correlation coefficient r2= 0.997. Moreover, the method was found to be highly sensitive with LOD (4.3μg/ml) and LOQ (13.07μg/ml). Conclusion: Based on results the proposed method can be successfully applied for the assay of Imatinib in various pharmaceutical dosage forms.


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