Abstract

Development and Validation of Spectroscopic Methods for the Estimation of Mupirocin Calcium in Bulk and in Ointment Formulation Objective: To develop and validate simple, precise and cost effective spectroscopic methods for estimation of Mupirocin calcium and pertain the same to its formulation. Methods: Four methods was proposed in the present work, the maximum absorbance was showed at 221 nm in zero order derivative spectroscopy (method A), scanned at 212- 229 nm in area under curve for zero order derivative spectroscopy (method B), 235 nm in first order derivative spectroscopy (method C) and 227.50-243.50 nm in area under curve for first order derivative spectroscopy (method D). The drug follows Beer- Lambert’s law in the concentration range of 4- 24 µg/mL and exhibited good correlation coefficient (r2 =0.999). Results: The proposed methods are effectively applied to its ointment formulation across all validation studies as per ICH guidelines. Excellent mean recovery studies for precision, repeatability, ruggedness and sensitivity results showed that the method has been validated successfully, the results are also in accordance for the % RSD values obtained within specified limits. Conclusion: Thus obtained results proved that all methods can be employed for routine analysis of Mupirocin calcium in bulk as well as in the commercial ointment formulation.

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