DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF SULBACTUM AND AMPICILLIN (SULTAMICILLIN)
Abstract
Two new, simple, sensitive and economical UV spectrophotometric methods were developed for the simultaneous analysis of Sulbactum and Ampicillin in bulk and in pharmaceutical formulations (SULTAMICILLIN).
Analytic method development and validation are continuous and interconnected activities conducted throughout the drug development process. The practice of validation verifies that a given method measures a parameter as intended and establishes the performance limits of the measurement. Although apparently contradictory, validated methods produce results within known uncertainties. These results are crucial to continuing drug development, as they define the emerging knowledge base supporting the product.
The time and effort that are put into developing scientifically-sound, robust, and transferrable analytic methods should be aligned with the drug development stage. The re-sources that are expended on method validation must be constantly balanced with regulatory requirements and the probability for product commercialization.
Method I is based on solving simultaneous equation. Sulbactum and Ampicillin show absorbance maximums at 272 and 332 nm respectively, so absorbance was measured at the same wave lengths for the estimation of Sulbactum and Ampicillin.
Method II is based on determination of Q-value. Both drugs (Sulbactum and Ampicillin) obey the Beer Lambert's law in the concentration range of 5-30 µg/mL and the correlation coefficient values were found to be 0.9994 and 0.999 respectively Methods are validated according to ICH guidelines and can be adopted for the routine analysis of Sulbactum and Ampicillin in pure and tablet dosage form of SULTAMICILLIN. The developed methods were validated and from the statistical data, it was found that the methods were linear, accurate and precise and can be successfully applied for the analysis of pharmaceutical formulations without interference of excipients. The proposed method is simple, selective and sensitive.
Key words: Sulbactum, Ampicillin, estimation, ICH, validation
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