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Journal of Pharmaceutical and Medicinal Chemistry

Volume  10, Issue 2, July - Dec 2024, Pages 57-61
 

Original Article

Spectrophotometric Determination and Validation of Clotrimazole in Pharmaceutical Formulations

Archana S.1, G. Bhavani2

1Associate Professor, 2Assistant Professor, Department of Pharmaceutical Analysis, Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada 521108, Andhra Pradesh, India.
 

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DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.10224.3

Abstract

Aim: A simple, sensitive, and cost-effective spectrophotometric method has been developed and validated for the determination of clotrimazole in pharmaceutical formulations. Settings and Method: The method is based on the measurement of absorbance at a specific wavelength (250 nm) in a methanolic solution. The linearity, precision, accuracy, limit of detection (LOD), limit of quantitation (LOQ), and robustness were investigated according to ICH guidelines. Results: The proposed method showed excellent linearity in the range of 1-25 µg/mL with a correlation coefficient (r) of 0.9998. The results indicated that the method is suitable for routine quality control analysis of clotrimazole in bulk and tablet formulations. Conclusion: The method is validated according to ICH guidelines and all the parameters are under the limits and used for routine analysis labs.
 


Keywords : Spectrophotometry, ICH guidelines, Validation parameters.
Corresponding Author : Archana S