SIMULTANEOUS HPTLC ANALYSIS OF ATORVASTATIN CALCIUM, EZETIMIBE, AND FENOFIBRATE IN TABLET

Abstract

A simple, sensitive HPTLC method has been developed and validated for the simultaneous estimation of atorvastatin calcium, ezetimibe, and fenofibrate in tablet dosage form. Chromatographic separation was performed on aluminum plates precoated with silica gel 60 F₂₅₄ with toluene:chloroform:methanol:glacial acetic acid (4.6:3:1.4:0.1, v/v/v/v) as mobile phase. The drugs were well resolved with R_F values 0.20 ± 0.01, 0.33 ± 0.01, and 0.80 ± 0.02 for atorvastatin calcium, ezetimibe, and fenofibrate, respectively. Densitometric evaluation of the separated zones was performed at 253 nm. The method was validated in terms of linearity, accuracy, precision, and specificity. The calibration curve was found to be linear between 0.2 and 0.8 µg/spot for atorvastatin calcium (r² = 0.999), 0.2 and 0.8 µg/spot for ezetimibe (r² = 0.998), and 4 to 16 µg/spot for fenofibrate (r² = 0.997). The limit of detection was found to be 0.019 µg/spot, 0.023 µg/spot, and 1.449 µg/spot for atorvastatin calcium, ezetimibe, and fenofibrate, respectively. The limit of quantitation was found to be 0.059 µg/spot, 0.068 µg/spot, and 4.390 µg/spot for atorvastatin calcium, ezetimibe, and fenofibrate, respectively. The proposed method can be used for estimation of the mentioned drugs in combined dosage form.

Keywords:

• atorvastatin calcium
• densitometry
• ezetimibe
• fenofibrate
• HPTLC
• validation

ACKNOWLEDGMENT

We thank Intas Pharmaceuticals, Torrent Research Center and Sun Pharma for providing standards of ATO, EZE, and FEN as gift samples.

Notes

*ATO, **EZE, ***FEN.