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2 Acta Chromatographica

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Simultaneous estimation of atorvastatin calcium and aspirin in combined dosage form by liquid chromatographic method

Shah D. A, Bhatt K. K, Baldania S. L

Acta Chromatographica

2012

Vol. 24, no. 1

51--64

An isocratic reversed-phase liquid chromatograpic assay method was developed for the quantitative determination of atorvastatin and aspirin (ASP) in combined dosage form. A Phenomenex Gemini C-18, 5-μm column with mobile phase containing 0.02 M potassium dihydrogen phosphate-acetonitrile-methanol (30:30:40, v/v/v) adjusted to pH 3 using o-phosphoric acid was used. The flow rate was 1.0 mL min -1 and effluents were monitored at 240 nm. The retention times (RTs) of atorvastatin calcium (ATV) and ASP were 10.5 and 3.8 min, respectively. ATV and ASP stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation, and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their RT values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision, and robustness. The method was successfully applied to the estimation of ATV and ASP in combined capsule dosage forms.

HPTLc method development and validation for analysis of risperidone in formulations, and in-vitro release study

Patel R. B, Patel B. G, Patel M. R, Bhatt K. K

Acta Chromatographica

2010

Vol. 22, no. 4

549--567

A new, simple, and rapid high-performance thin-layer chromatographic method has been established for quantitative analysis of risperidone. Chromatography was performed on silica gel 60 F 254 plates with methanol-ethyl acetate 8.0:2.0 ( v / v ) as mobile phase. Risperidone was quantified by densitometric analysis at 285 nm. The method gave compact bands for the drug ( R F 0.34 ± 0.01). Linear regression analysis of calibration data revealed a good linear relationship ( r 2 = 0.9996) between response and amount of risperidone in the range 100–600 ng per band. The method was validated for precision, recovery, repeatability, linearity, specificity, and robustness in accordance with ICH guidelines. The minimum detectable amount was 22.44 ng per band and the limit of quantification was 68.01 ng per band. Statistical analysis of the results showed the method enabled precise, accurate, reproducible, and selective analysis of risperidone. The method was successfully used for estimation of the equilibrium solubility of risperidone, and for quantification of risperidone as the bulk drug in a commercially available preparation, in in-house-developed mucoadhesive microemulsion formulations, and in solution.