title: Determination of inorganic nitrate impurity from nicorandil and its tablet dosage form by simple reversed phase liquid chromatographic method.
abstract: A simple, fast, precise, specific and economical reverse phase liquid chromatographic method was developed for determination of nitrate (NIT) impurity from nicorandil (NIC) and its tablet dosage form. NIT is process impurity as well as a degradation product of NIC. This article is based on application of amino propyl silane (APS) column for determination of NIT in presence of NIC and various excipients using potassium nitrate as a standard. The developed method was validated for its intended use by evaluating various important parameters like linearity, accuracy, recovery and specificity. The developed method was applied to evaluate the compatibility study of NIC with various excipients by monitoring the NIT content.
authors.affiliation: Torrent Research Center, C/O Torrent Pharmaceutical Ltd., Indira Bridge, Bhat, Gandhinagar, 382428 Gujarat, India. tusharmehta@torrentpharma.com
authors.forename: Tushar N
authors.initials: TN
authors.lastname: Mehta
authors.forename: Manoj P
authors.initials: MP
authors.lastname: Gadhvi
authors.forename: Gunta
authors.initials: G
authors.lastname: Subbaiah
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D020108:Nicorandil / Q000032:analysis*; D009566:Nitrates / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013607:Tablets / Q000032:analysis
chemical_list: D009566:Nitrates; D013607:Tablets; D020108:Nicorandil