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Abstract

Determination of simvastatin, pravastatin sodium and rosuvastatin calcium in tablet dosage forms by HPTLC

Author(s): BG Chaudhari1, NM Patel2, PB Shah1
1 Shri B. M. Shah College of Pharmacy, Modasa-383 315, India 2 Shri B M Shah College of Pharmaceutical Education and Research, Modasa-383 315, India

Correspondence Address:
B G Chaudhari Shri B. M. Shah College of Pharmacy, Modasa-383 315 India E-mail: chaudharypatel@rediffmail.com


Simple and reproducible HPTLC method was developed for the separation and quantitation of simvastatin, pravastatin sodium and rosuvastatin calcium, cholesterol lowering agents in pharmaceutical dosage forms. The stationary phase used was precoated silica gel 60F 254 . The mobile phase used was a mixture of chloroform:methanol:toluene (6:2:2, v/v/v). The method has been completely validated and proved to be rugged. Calibration curves were linear over the studied ranges with correlation coefficients grater than 0.999. All the drugs were extracted from the respective tablets using methanol. The percentage recoveries ranged from 100 to 101 for simvastatin, 98 to 101 for pravastatin sodium and 98 to 102 for rosuvastatin calcium. The LOD for simvastatin, pravastatin sodium and rosuvastatin calcium were found to be 15, 9 and 8 ng/spot, respectively and LOQ were 200 ng/spot for simvastatin and 100 ng/spot for pravastatin sodium and rosuvastatin calcium. The method can be useful in the quality control of bulk manufacturing and tablet dosage forms.

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