Comparative validation of UV-spectrophotometry and RP-HPLC methods for cefixime and moxifloxacin analysis

This study presents the development and validation of UV-spectrophotometry and RP-HPLC methods for the simultaneous quantification of Cefixime Trihydrate (CEFI) and Moxifloxacin Hydrochloride (MOXI) in pharmaceutical formulations. Two UV-spectrophotometric methods, including the absorbance ratio (Q-Absorption) and First Order Derivative Spectroscopy, were developed and validated for their linearity, precision, accuracy, and sensitivity. Additionally, a robust RP-HPLC method using a C18 column and optimized mobile phase was employed for efficient separation and simultaneous estimation of CEFI and MOXI. All methods were validated in accordance with ICH guidelines, with system suitability parameters confirming the reliability of the RP-HPLC method for routine analysis. The absorbance ratio and First Order Derivative methods demonstrated low %R.S.D values, high accuracy, and satisfactory sensitivity for both drugs. Similarly, the RP-HPLC method achieved high resolution, precision, and robustness. Statistical analysis through ANOVA revealed no significant differences between the methods in terms of accuracy and precision. The methods were applied to analyze marketed formulations, further confirming their applicability in routine quality control. In conclusion, the validated methods provide accurate, precise, and sensitive techniques for the simultaneous estimation of CEFI and MOXI, making them suitable for pharmaceutical quality control and regulatory compliance. [Display omitted] •UV, derivative, and RP-HPLC validated for accuracy, precision, and robustness.•Absorbance ratio method ensures low %RSD for CEFI and MOXI estimation.•First-order derivative method effectively estimates CEFI and MOXI.•RP-HPLC with C18 column ensures separation and resolution of CEFI, MOXI.•ANOVA shows no significant differences in methods for CEFI, MOXI.