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Development and Validation of sensitive HPTLC method for quantitative analysis of fluvastatin sodium in bulk and pharmaceutical dosage form
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| Author:
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ASHOK AKABARI, UMANG SHAH, SAGAR SOLANKI, MANDEV B PATEL , BHANUBHAI N SUHAGIA
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| Abstract:
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A simple, sensitive and robust high performance thin layer chromatography method for determination of fluvastatin sodium in capsules dosage form has been developed and validated. Fluvastatin sodium from the formulations was separated and identified on aluminium backed silica gel 60 F254 HPTLC plates as a stationary phase using methanol–ethyl acetate-toluene-glacial acetic acid (3:5:1.8:0.2, v/v/v/v) as mobile phase. Densitometry scanning was performed in absorbance mode at 235 nm. Well-resolved bands were obtained of fluvastatin sodium in bulk and capsules dosage form. The plates were developed to a distance of 8 cm. Percentage relative standard deviation of intra-day and inter day precision, were found 0.59 -0.95% and 0.9 -1.73 % respectively. Statistical analysis proved that the method was precise, accurate and robust. The limits of detection and quantification were 26.74 and 81.05ng/band. The method was fully validated for linearity, specificity, accuracy, precision, repeatability, and robustness to prove its suitability for determination of fluvastatin sodium in bulk and capsule dosage form in accordance with ICH guidelines.
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| Keyword:
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Fluvastatin Sodium, HPTLC, Anti-Hyperlipidemic agent, Densitometric analysis, Validation
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| EOI:
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| DOI:
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