Development and validation of a liquid chromatographic method for determination of related-substances of mosapride citrate in bulk drugs and pharmaceuticals.
An isocratic reversed-phase high-performance liquid chromatographic (RP-HPLC) method for determination and evaluation of purity of mosapride citrate in bulk drugs and pharmaceuticals has been developed using Waters Symmetry C(18) column with acetonitrile:0.024 M orthophosphoric acid (28:72, v/v) adjusted to pH 3.0 with triethylamine and photodiode array detector set at 276 nm. The method is simple, rapid, selective and capable of detecting all process related impurities at trace levels in the finished products with detection limits ranging in between 0.2 x 10(-8)g and 6.4 x 10(-8)g. The method has been validated with respect to accuracy, precision, linearity, ruggedness, and limit of detection and quantification. The linearity range was 125-1000 microg/ml. The percentage recoveries from pharmaceutical dosages were ranged from 95.53 to 100.7. The method was found to be suitable not only for monitoring the reactions during the process development but also quality assurance of mosapride citrate.
Nageswara Rao
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HPLC/UV Group, Division of Analytical Chemistry, Discovery Laboratory Indian Institute of Chemical Technology, Hyderabad 50 0007, India. rnrao@ins.iictnet.com
Nagaraju
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D
Alvi
S N
SN
Bhirud
S B
SB
D001549:Benzamides / Q000032:analysis* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid / Q000379:methods; D004340:Drug Contamination; D009025:Morpholines / Q000032:analysis* / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry
D001549:Benzamides; D009025:Morpholines; D004364:Pharmaceutical Preparations; C062720:mosapride