Estimation of pitavastatin calcium in tablet dosage forms by column liquid chromatography and ultraviolet spectrophotometry.
Two simple and accurate methods for the determination of pitavastatin calcium (PIT) in tablet dosage forms were developed and validated using column liquid chromatography (LC) and UV spectrophotometry. The LC separation was achieved on a Phenomenex Luna C18 column (250 mm, 4.6 mm id, 5 microm) in the isocratic mode using acetonitrile-water-triethylamine (80 + 19.8 + 0.2, v/v/v), adjusted to pH 3.5 +/- 0.05 with orthophosphoric acid, as the mobile phase at a flow rate of 1.5 mL/min. The retention time was 5.70 min. Both the methods were performed at 238 nm, the wavelength of maximum absorbance of PIT in methanol. In the LC method, quantification was achieved with a photodiode array detector over the concentration range of 0.1-2.5 microg/mL with a mean recovery of 100.26 +/- 0.75%. In the UV method, quantification was achieved over the concentration range of 2-20 microg/mL with mean recovery of 99.65 +/- 1.24%. Both methods were validated, and the results were compared statistically. They were found to be simple, specific, accurate, and precise. The methods were successfully applied for the determination of PIT in tablet dosage form without any interference from common excipients.
Panchal
Hiral J
HJ
Shree S.K. Patel College of Pharmaceutical Education and Research, Department of Pharmaceutical Chemistry, Ganpat Vidyanagar, Kherva, Mehsana-382711, Gujarat, India. hir_143_2003@yahoo.com
Suhagia
Bhanubhai N
BN
Patel
Madhabhai M
MM
Patel
Bhavesh H
BH
D002853:Chromatography, Liquid / Q000379:methods; D004304:Dosage Forms; D006863:Hydrogen-Ion Concentration; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000032:analysis / Q000737:chemistry; D007700:Kinetics; D008958:Models, Molecular; D011804:Quinolines / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013607:Tablets / Q000032:analysis*
D004304:Dosage Forms; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; D013607:Tablets; C108475:pitavastatin