Estimation of Ceftazidime and Tazobactam in an Injectable Dosage Form. Analytical Method Development & Validation

      Аннотация: A fixed dose combination of Ceftazidime(CEF) and Tazobactam(TAZO) is used as powder form of injection for the treatment of resistant lower respiratory tract and other infections. Stability indicating RP-HPLC and HPTLC methods were developed and validated for estimation of CEF and TAZO in an injection. RP-HPLC method was linear in the concentration range of 80-480 µg/mL and 10-60 µg/mL with R2 of 0.9998 and 0.9989 for CEF & TAZO respectively. Both the drugs were susceptible to acidic, alkaline and oxidative hydrolysis conditions. HPTLC method was linear in the concentration range of 1000-6000 ng/band for CEF and 2000-12000 ng/band for TAZO with R2 of 0.9993 and 0.9991 for respective drugs. The present work describes simple, economical and non interfering methods for estimation of CEF & TAZO. The methods were validated and found to be sensitive, accurate and precise. Percentage recovery shows that the method is free from interference of the excipients used in the formulation. Therefore, the proposed methods can be used for routine analysis. The method effectively separated the drugs from their degradation products so it can be used as a stability-indicating assay method.

Ключевые слова: validation, RP-HPLC, HPTLC, Tazobactam, Ceftazidime