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

Author(s):  
Anuja Suryawanshi ◽  
Afaque Ansari ◽  
Mallinath Kalshetti

Objective: A new, simple, economical, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the estimation of luliconazole in pure form and pharmaceutical formulation as per ICH guidelines. Method: A UV spectrophotometric method has been developed using methanol and water as solvent to determine the luliconazole in bulk and pharmaceutical dosage formulation. The λmax of luliconazole in methanol and water was found to be 297nm. Results: The drug was proved linear in the range of 3-15µg/ml and exhibited good correlation coefficient (R2= 0.9993) and excellent mean recovery (98-99%). The % RSD for intra-day and inter-day precision was found to be 1.051288 and 1.138658 respectively. The LOD and LOQ of Luliconazole was found to be 1.1168µg/ml and 3.3845µg/ml respectively. This method was successfully applied to luliconazole content in marketed brands and results were in good agreement with the label claims. Conclusion: The method was validated for linearity, precision, repeatability and reproducibility. The obtained results proved that the method can be employed for the routine analysis of luliconazole in bulks as well as in commercial formulations.

Author(s):  
SUSHMITA KANKURE ◽  
MALLINATH KALSHETTI ◽  
RAVIKANT PATIL

Objective: The objective of the present work is to develop a simple, rapid, economic UV spectrophotometric method for quantification of clenbuterol hydrochloride in bulk and pharmaceutical formulation as per ICH guidelines. Methods: A UV spectrophotometric method has been developed using water as solvent to determine the Clenbuterol hydrochloride in bulk and pharmaceutical dosage formulation. The λmax of Clenbuterol hydrochloride in water was found to be 242 nm. Results: The drug was proved linear in the range of 10-50μg/ml and exhibited good correlation coefficient (R2 = 0.9987) and excellent mean recovery (98-100%). The %RSD for intra-day and inter-day precision was found to be 0.053997676 and 0.359081556 respectively. The LOD and LOQ of clenbuterol hydrochloride was found to be 3.704448 and 11.2256 respectively. This method was successfully applied to clenbuterol content in marketed brands and the results were in good agreement with the label claims. Conclusion: The method was validated for linearity, precision, repeatability and reproducibility. The obtained results proved that the method can be employed for the routine analysis of clenbuterol in bulks as well as in commercial formulations.


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):  
ANJALI P. KOKANE ◽  
VARSHA S. TEGELI ◽  
BHAGYASHRI S. SHINDE

Objective: The current work intended towards the developed and validated by using Simple, rapid, sensitive, precise and specific method UV Spectrophotometric method for the estimation of Ipratropium bromide in API and pharmaceutical formulation. Methods: Water used as a solvent and the absorbance of the drug was measured at the absorbance’s maxima of Ipratropium bromide λmax is 214 nm. Result: Calibration curve plotted in concentration range 20-120µg/ml exhibit the linearity relationship with line equation y=0.0062x+0.3161 and r2=0.995. The Accuracy was found to be 99.5-100.1%, the precision %RSD= 0.12888-0.30533, and the LOD and LOQ is 8.78266-28.5881. The method was found to comply with all the validation parameters as per ICH guidelines indicating the sensitivity of the method towards analyte. Conclusion: The method can be used satisfactory for the routine analysis of Ipratropium Bromide present in API and Pharmaceutical dosage form.


2021 ◽  
Vol 11 (2) ◽  
pp. 241-248
Author(s):  
Bhavya sri Khagga ◽  
Kavya.Parelli

The main purpose of this study was to develop a simple precise, rapid and accurate UV-visible spectrophotometric method for determination of Bumetanide in spiked human urine by extracting the Bumetanide from spiked human urine using ethyl acetate after extraction it was scanned between 200-400nm by using UV detector and its absorbance maxima was found to be 222nm.The calibration curve was linear in the range of 1-17 µg/ml. .the recovery and assay studies of bumetanide were within 93-94.85% indicating that the proposed method can be estimation of bumetanide.


Author(s):  
Zainab A. Bagalkote ◽  
Ganesh Gajeli

Objective: A new, simple, sensitive, precise, reproducible UV visible spectrophotometric method was developed for the estimation of Carbimazole in Tablet dosage form. Methods: The UV spectrum of Carbimazole in methanol and distilled water (30:70) showed λ max at 289.6nm. Beer’s law is valid in the concentration range of 10-50µg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-50µg/ml with the regression equation y = 0.0232x + 0.0466, and regression coefficient i.e, r2= 0.9992 moreover, the method was found to be highly sensitive with LOD (1.818µg/ml) and LOQ (5.509µg/ml). Conclusion: From the results it can be concluded that the given method can be successfully applied for assay of Carbimazole in Tablet dosage form.


Author(s):  
SAILI MADUR ◽  
VINOD MATOLE ◽  
MALLINATH KALSHETTI

Objective: A new, simple, sensitive, precise, reproducible UV visible spectrophotometric method was developed for the determination of Dasatinib in Tablet dosage form with­­­ methanol. Methods: The method is based on the formation of a colorlesscomplex. The UV spectrum of Dasatinib in methanol showed maximum wavelength at 248 nm. Beer’s law is valid in the concentration range of 7-35µg/ml. this method was validated for linearity, accuracy, precision, assay, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 7-35µg/ml with the regression equation y = 0.0332x+0.0633 and regression coefficient i.e. r2= 0.9994moreover, the method was found to be highly sensitive with LOD(1.08µg/ml) and LOQ(3.29µg/ml). Conclusion: Based on the results the proposed method can be successfully applied for the assay of Dasatinib in various tablet dosage forms.


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):  
Yelekar P D ◽  
Chaudhari S.B ◽  
Chourasia R D ◽  
Tikariya K R ◽  
Badole Payal

Objective: The main objective of the work was to check the label claim of tablet in combination by Simultaneous estimation by UV method. Method: Spectrophotometric method development and validation are plays important role in the development and manufacture of pharmaceuticals. This Spectrophotometric method was a simple and reproducible for the quantitative determination of Paracetamol and Caffeine in tablet formulation was developed and validated in the present work. The various parameters like specificity, linearity, precision, accuracy, robustness and ruggedness were studied according to ICH guidelines. The wavelength 273nm was selected for the estimation of Caffeine using distilled water as a solvent and the wavelength 243nm selected for the estimation of Paracetamol using distilled water as solvent the drug obeyed Beer’s-Lambert’s law over the concentration range 20-120µg/ml. Recovery study was performed to confirm the accuracy of the method. The method was successfully applied for routine analysis of this drug in formulation the method were validated as pr ICH guidelines. Conclusion: A simple UV spectrophotometric method was developed for the Simultaneous determination of Paracetamol and Caffeine in tablet formulation without any interference from the excipients. The present method succeeded in adopting a simple sample preparation that achieve satisfactory extraction recovery and facilitated its application in co formulated formulation.


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