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DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF VITAMIN-D3 IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

Journal: Indian Drugs (Vol.53, No. 6)

Publication Date:

Authors : ; ; ; ; ; ;

Page : 40-45

Keywords : ;

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Abstract

An accurate, simple, rapid, sensitive and cost effective method for the determination of Vitamin-D3 in pharmaceutical dosage form was developed and validated by RP-HPLC method. Chromatographic separation was achieved on phenomenex C18 column (150 mm X 4.6 mm, 5μm) using methanol: acetonitrile: water (90:5:5 V/V/V) as mobile phase, at a flow rate of 1.5 mL/min. The retention time of Vitamin-D3 was found to be 8.3 minutes; the detection was monitored at 265 nm by using UV detector. The developed method was validated according to International Conference on Harmonization (ICH) guidelines. The linearity of Vitamin-D3 was in the range of 2.50 ppm to 6.00 ppm. This method showed an excellent linear response with the correlation coefficient (R2) value of 0.999 for the Vitamin-D3. The recovery of the drug ranged from 99.59% to 103.83% with an average of 101.34%. The percentage RSD was found to be less than two, indicating high degree of accuracy and precision of the proposed RPHPLC method. Due to simplicity, cost effectiveness, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis of Vitamin-D3 in bulk drug and pharmaceutical dosage forms.

Last modified: 2017-08-23 14:30:55