Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF CODEINE PHOSPHATE AND IBUPROFEN IN BULK AND PHARMACEUTICAL FORMULATIONS

Abhiram K.N.*, Vijaya Krishna C. Aradhya, A. Satish Kumar Shetty, Manzoor Ahmed Anil Kumar S. M. and Siddalinga Swamy M. S.

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC with subsequently validate as per ICH guidelines for the determination of Codeine phosphate (COD) and Ibuprofen (IBU) using mobile phase [mixture of 1-octane sulfonic acid and methanol in the ratio 30:70] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 220.0 nm was selected as the analytical wavelength. The retention time of COD and IBU was found to be 2.627 and 4.248 respectively. The linearity of the proposed method was investigated in the range of 10-30 μg/ml (r2= 0.9998) for COD and 50-250 μg/ml (r2=0.9996) for IBU respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.

Keywords: RP-HPLC method, Codeine phosphate, Ibuprofen, Validation.