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Abstract
A Rapid Resolution Reversed Phase High-Performance Liquid Chromatography (RR RP-HPLC) method has been developed and validated for the simultaneous determination of atorvastatin and seven related compounds specified as impurities. Experimental design was used during method optimization (full factorial 32 design) and robustness testing (central composite design). Chromatography was performed with mobile phase containing phosphate buffer pH 3.5 and a mixture of 10% (v/v) tetrahydrofuran in acetonitrile as organic modifier. A Zorbax Eclipse XDB C18 Rapid Resolution HT 4.6 mm × 50 mm, 1.8 µm particle size column was used. The developed method allowed determination of Atorvastatin Calcium (ATV Ca) purity and level of impurities in drug substances.
Notes
∗Eluted peak pairs refer to the text.
∗∗Organic phase variation during gradient elution.
t r = retention time, k = capacity factor, ∗Eluted peaks: (1) ATV eliminate, (2) desfluoro ATV, (3) trans ATV, (4) ATV Ca, (5) diamino ATV, (5) ATV lactone, (7) ATV dihydroxy, (8) ATV diketone.
∗Eluted peak pairs refer to the text.
∗Eluted peaks: (1) ATV eliminate, (2) desfluoro ATV, (3) trans ATV, (4) ATV Ca, (5) diamino ATV, (6) ATV lactone, (7) ATV dihydroxy, (8) ATV diketone, a = intercept, b = slope, Sa = standard deviation of the intercept, Sb = standard deviation of the slope, R 2 = coefficient of correlation, LOD = limit of detection, LOQ = limit of quantification.
∗Impurities: (1) ATV eliminate, (2) desfluoro ATV, (3) trans ATV, (4) diamino ATV, (5) ATV lactone, (6) ATV dihydroxy, (7) ATV diketone, ∗∗S = standard deviation (n = 5).
∗Eluted peak pairs refer to the text.
∗Eluted peak pairs refer to the text.
