Thu, 23 Nov 2017

UV Spectrophotometric Method Development and Validation for Determination of Levocetirizine Dihydrochloride

Farhana Lipi*1, Shahida Parvin2, Md.Rabiul Islam1

1.Pharmacy Discipline, Khulna University, Khulna-9208, Bangladesh.

2.Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh.


ABSTRACT

Levocetirizine Dihydrochloride is an orally active, non-sedative antihistamine drug. To determine the assay content of Levocetirizine Dihydrochloride drug substance, a very simple, accurate, specific and precise UV- spectrophotometric method has been built up as well as evaluated. The suggested method comprises dissolving Levocetirizine Dihydrochloride in 0.1M Hydrochloric acid solution and subjecting the consequential solution to UV Spectroscopic measurement. An Absorption maximum was found to lie at about 231nm and the measurements were carried out at this wavelength. Beer's law was followed in the concentration range of 7.5 to 22.5 μg/mL. The linearity showed on the calibration curve between concentration and absorbance by the line equation of y = 0.0377x - 0.0043 (R² = 0.9992). Reproducibility by repeating methods as %RSD was found to be less than 2%. The results of the accuracy and precision were found very satisfactory and here the suggested method was statically validated as per the ICH guidelines in terms of the specificity, linearity, accuracy, precision and robustness. Validation studies have discovered that the method is simple, specific, rapid, reproducible, precise, accurate and economical which is useful for the routine analysis of Levocetirizine Dihydrochloride

Keywords: Spectrophotometry, Levocetirizine Dihydrochloride, Assay, Validation. 


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