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Method development and validation for the analysis of Penciclovir and related impurity in bulk and pharmaceutical dosage forms by RP HPLC

Shiny Ganji* and D.Satyavati

The prime aim of the current work is to develop and validate a novel, specific, sensitive, precise, rapid and faster isocratic elution RP HPLC method for estimation of Penciclovir and its process related impurity in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved on Hypersil phenyl, 250 mm X4.6 mm, 5 μ with mobile phase composed of 0.1% orthophosphoric acid in 1000 ml of water and acetonitrile in the ratio of 60:40 using an isocratic mode. The temperature is maintained at 30oC, detection was made using UV detector and LC solution software at 254 nm and the flow rate was maintained at 1.0ml/min. The run rate was 20 min. The developed method was validated according to ICH guide lines. The linearity of calibration curve for each analyte in concentration range of 1200μg/ml – 3600μg/ml was good. The curve was linear for the impurity in concentration range of 8 - 24μg/ml. There exists a good correlation between peak area and analyte concentration. Relative standard deviation values for penciclovir is 0.111 and its process related impurity is 0.359. LOD for the active ingredient and its impurity was found to be 0.02 % and 0.5 % respectively. LOQ for active ingredient and its impurity was found to be 0.06 % and 0.15% respectively. Statistical analysis revealed that the proposed method was found to be highly sensitive, precise, accurate, robust and fast. The shorter retention time allows the analysis of large number of samples in short period of time and it is cost effective, so it can be successfully applied for routine analysis of active pharmaceutical ingredients and related impurities in bulk and pharmaceutical dosage forms.

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