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Development and Validation of RP–HPLC Method for Simultaneous Estimation of Cefepime and Tazobactam in Injection Formulation


Affiliations
1 Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
     

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A new, rapid, highly sensitive, economical and accurate RP-HPLC method was developed for simultaneous estimation of Cefepime and Tazobactam in injection formulation. The separation was achieved by C18 column (150 × 4.6 mm, 5 μ particle size) with mobile phase consisting of phosphate buffer (pH 2.4, diluted with orthophosphoric acid), methanol and acetonitrile in the ratio of 90:5:5 v/v, using flow rate 1.1 mL/min and eluents monitored at 260 nm. The developed method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection and limit of quantification. The retention times of cefepime and tazobactam were 2.236 and 4.498 min respectively. The linearity was found to be in the range of 250-750 μg/mL and 31.25-93.75 μg/mL for cefepime and tazobactam sodium respectively, had regression coefficients (R2) 0.999. The proposed method was successfully applied for simultaneous estimation of both drugs in injection formulation.

Keywords

RP-HPLC, Cefepime, Tazobactam, Injection, Validation.
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  • Development and Validation of RP–HPLC Method for Simultaneous Estimation of Cefepime and Tazobactam in Injection Formulation

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Authors

N. Sunitha
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
L. Sindhura
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
B. Thangabalan
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
S. Manohar Babu
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India

Abstract


A new, rapid, highly sensitive, economical and accurate RP-HPLC method was developed for simultaneous estimation of Cefepime and Tazobactam in injection formulation. The separation was achieved by C18 column (150 × 4.6 mm, 5 μ particle size) with mobile phase consisting of phosphate buffer (pH 2.4, diluted with orthophosphoric acid), methanol and acetonitrile in the ratio of 90:5:5 v/v, using flow rate 1.1 mL/min and eluents monitored at 260 nm. The developed method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection and limit of quantification. The retention times of cefepime and tazobactam were 2.236 and 4.498 min respectively. The linearity was found to be in the range of 250-750 μg/mL and 31.25-93.75 μg/mL for cefepime and tazobactam sodium respectively, had regression coefficients (R2) 0.999. The proposed method was successfully applied for simultaneous estimation of both drugs in injection formulation.

Keywords


RP-HPLC, Cefepime, Tazobactam, Injection, Validation.