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Title: Analytical method development and method validation for assay, related substances and degradants of acyclovir and valacyclovir as antiviral drug products
Researcher: Holkar, Ganesh Shahanebuwa
Guide(s): Rokade, Manoj D
Keywords: Chemistry
Upload Date: 11-Dec-2013
University: Shri Jagdishprasad Jhabarmal Tibarewala University
Completed Date: 31-12-2012
Abstract: From the Literature study it is unable to find the combined HPLC methods for Acyclovir and Valacyclovir using HPLC-UV detector. However, an analytical method for individual analysis for Acyclovir and Valacyclovir was published. So It is felt necessary that to develop HPLC method for quantitative determination of Acyclovir and Valacyclovir. It was also found that there are some analytical methods reported for the Acyclovir and valacyclovir separately and most of the works reported were done on the biological fluids. Based upon the data of previous literature review and results of published methods, the trials of method development taken and finalized the method for validation of assay and related substances with degradants study. The finalized method is achieved on HPLC column Inertsil cyno column, (250and#61620;4.6mm dimensions) having particle size 5and#61549;m, with flow rate as 0.8 ml/ min and column oven temperature as 50o C. The buffer was prepared by dissolving 1.00 g of Ammonium acetate in 1000 ml water, filtered through 0.45µm membrane filter and degassed in ultrasonic bath prior to use as mobile phase A . Acetonitrile is the organic solvent used as mobile phase B in isocratic mode. The injection volume amounted to 5and#61549;l. The analysis was carried out under isocratic condition as mobile phase A: Mobile phase B is (95:5). Detection was monitored at the wavelength of 254 nm. Diluent used was a mixture of acetonitrile and water in the ratio of (50:50) in the preparation of analytical solutions. According to the International Conference on Harmonization (ICH) guidelines taking into consideration the specified limits for Acyclovir and Valacyclovir Tablets and based upon the results obtained from the method validation are summarized below,
Pagination: 165p.
Appears in Departments:Faculty of Sciences

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01_title.pdfAttached File7.17 kBAdobe PDFView/Open
02_declaration.pdf5.6 kBAdobe PDFView/Open
03_certificate.pdf5.39 kBAdobe PDFView/Open
04_acknowledgements.pdf6.41 kBAdobe PDFView/Open
05_index.pdf52.97 kBAdobe PDFView/Open
06_list of tables.pdf23.35 kBAdobe PDFView/Open
07_list of figures.pdf13.97 kBAdobe PDFView/Open
08_abbreviations.pdf8.55 kBAdobe PDFView/Open
09_abstract.pdf32.72 kBAdobe PDFView/Open
10_chapter 1.pdf239.16 kBAdobe PDFView/Open
11_chapter 2.pdf654.42 kBAdobe PDFView/Open
12_chapter 3.pdf583.93 kBAdobe PDFView/Open
13_chapter 4.pdf292.98 kBAdobe PDFView/Open
14_chapter 5.pdf96.31 kBAdobe PDFView/Open
15_reference.pdf55.37 kBAdobe PDFView/Open

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