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1.
Adv Pharm Bull ; 5(3): 385-91, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26504761

ABSTRACT

PURPOSE: This paper describes a simple, precise and accurate RP-HPLC method for simultaneous estimation of atorvastatin and ezetimibe in plasma. METHODS: The chromatographic separation of the drugs were performed on an X-Terra C8 (4.6 x 150 mm, 3.5 mm), with phosphate buffer [pH 3.5 with Ortho Phosphoric Acid] - acetonitrile 40:60 (v/v) as mobile phase. The detection was performed at 235 nm. The flow rate was maintained at 1.2 mL/min. The run time was 8.0 min. RESULTS: The accuracy and reliability of the method was assessed by evaluation of linearity (5-25 µg/mL for both atorvastatin calcium and ezetimibe), precision (intra-day RSD 0.57 % and inter-day RSD 0.02 % for atorvastatin calcium and intra-day RSD 0.56 % and inter-day RSD 0.1 % for ezetimibe), accuracy (100.08- 100.84 % for atorvastatin calcium and 100.56- 101.00 % for ezetimibe), and specificity, in accordance with ICH guidelines. The LLOQ obtained by the proposed method were 1.294 and 1.384 µg/mL for atorvastatin and ezetimibe respectively. CONCLUSION: Overall the proposed method was found to be suitable and accurate for the quantitative determination in plasma. The method was effectively separated the drug from plasma.

2.
Curr Drug Discov Technol ; 11(4): 259-70, 2014.
Article in English | MEDLINE | ID: mdl-25553432

ABSTRACT

This paper describes a new RP-HPLC method for simultaneous quantification of these compounds in the bulk sample drug as well as in tablet dosage forms. The chromatographic separation was performed on an XTerra C8 (4.6 x 250 mm; 5 µm), with phosphate buffer [pH 3.5] and acetonitrile in the ratio of 40:60 (v/v) as mobile phase. The detection was carried out at 240 nm. The accuracy was found to be 99.59% and 98.98% for atorvastatin and ezetimibe respectively. The linearity was 5-25 µg/ml for both the drugs. The intra-day RSD was 0.57% and inter-day RSD was 0.13% for atorvastatin calcium and intra-day RSD was 0.56% and inter-day RSD was 0.09% for ezetimibe. The validation of method was carried out utilizing ICH-guidelines.


Subject(s)
Atorvastatin/analysis , Chromatography, High Pressure Liquid , Chromatography, Reverse-Phase , Ezetimibe/analysis , Limit of Detection , Powders , Tablets
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