Analytical method development and validation studies for the estimation of H2 receptor antagonist drug (Ranitidine)

Renuka Manjunath, Deepak Kumar Jha


Background: An analytical science in the development, finding a new molecules and procreation of pharmaceuticals has been an extensive approached. From the evaluation over small quantities of complex biological substances to the quality monitoring of the finished dosage form, the use on analytical technology know- how covers an ample thoroughness over techniques or disciplines.

Methods: Reversed phase high performance liquid chromatography (RP-HPLC) approach has been promoted for the discernment over Ranitidine (RAN) within pharmaceutical dosage form split of RAN was accomplished inside a unaccompanied chromatographic run of an Phenomenix column size 5 μm 4.6x250 mm along with UV analysis at 227 nm wavelength, below isocratic conditions, using Ammonium acetate and Methanol (pH 6.0) in 80:20 ratio. Validation parameters had been observed in accordance with exhibit linearity, accuracy, precision, Limit of Quantitation and Limit of detection in conformity in imitation of ICH guidelines.  

Results: The contemporary approached demonstrates significant linearity upon the range concerning 50-202.5 μg/ml for RAN followed by intra-day and inter-day precision, expressed so the relative standard deviation (RSD), on replicates is <2.0 and accuracy among the range over 98-102%.

Conclusions: The flourished RP-HPLC technique was once innovative, suitable for detecting RAN in pure form and in pharmaceutical preparation.


Ammonium acetate, Methanol, Ranitidine, RP-HPLC, UV

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