Thursday , 13 June 2024

RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ceftazidime and Sulbactam in Bulk and Pharmaceutical Dosage

Vishal Bharat Babar1,*, Srikanth Kumar Karumanchi2, B. Siva Sai Kiran3
1*Dattakala College of Pharmacy, Swami-Chincholi, Bhigwan-413130, Pune Dist., Maharashtra, India.
2V. V. Institute of Pharmaceutical Sciences, Gudlavalleru-521356, Krishna Dist., Andhra Pradesh, India.
3JNTUA-Oil Technological & Pharmaceutical Research Institute, Ananthapuramu-515002, Andhra Pradesh, India.

The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredients of Ceftazidime and Sulbactam and their related substances. A simple, selective, validated and well-defined stability that shows gradient RP-HPLC methodology for the quantitative determination of Ceftazidime and Sulbactam. The chromatographic strategy utilized Column of C18 (150 mm x 4.6 mm, 5 µm), using isocratic elution with a mobile phase of 0.01N Na2HPO4 and Acetonitrile (55:45 %v/v). A flow rate of 1 ml/min and a detector wavelength of 270 nm utilizing the 2487 UV detector were given in the instrumental settings. Using the impurity-spiked solution, the chromatographic approach was streamlined. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. LOD and LOQ for the two active ingredients and their impurities were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of 0.999, which means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness was determined as a part of method validation and the results were found to be within the acceptable range. The proposed method to be fast, simple, feasible and affordable. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.

Keywords: Ceftazidime, Sulbactam, Method development, RP-HPLC, Validation

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