| Popis: |
Aim: To develop and validate a simple HPLC method for the determination of perindopril erbumine (PDE) in bulk and tablets. Place and Duration of Study: Rainbow Pharma Lab, Hyderabad, India, between April and June 2012. Methodology: The separation of PDE was carried out on a Zorbax XDB C8 (250 mm × 4.6 mm I.D., 5 μm particle size) analytical column. The mobile phase was phosphate buffer (pH 4.5)-acetonitrile (60:40 v/v). The flow rate and wavelength were set to 1.3 mL/min and 242 nm, respectively. As per ICH guidelines, the proposed method was validated. The developed method was successfully applied for the estimation of PDE in tablets and results were compared statistically with the official method. Results: The developed method showed a linear response from 8 to 80 μg/mL, with a regression coefficient (R2) of 0.9996. The LOD and LOQ were 2.4 and 8μg/mL, respectively. The selectivity studies showed that the method was selective and free from interfering common excipients. The intra- and inter-day RSD were in the range of 0.043-0.234% and 0.180-0.654%, respectively. The results of recovery studies were good. The stability data of the PDE indicate that the drug was stable for 72 hours. Conclusion: The developed method was linear, sensitive, selective, precise, accurate and robust, being suitable for routine quality control analyses of PDE. |
