A Validated Stability Indicating Reversed-Phase Hplc Method For Simultaneous Estimation For Assay And Preservatives Content Of Butalbital, Acetaminophen, Caffeine Oral Solution 50mg/325mg/40mg Per 15 Ml

Abstract

A quick, simple and stability indicating reverse-phase HPLC method was developed and validated for estimation of Assay and Preservative content of Butalbital, Acetaminophen, Caffeine Oral Solution 50mg/325mg/40mg per 15 mL and Preservatives-Methylparaben and Propylparaben, in accordance with the ICH Q2R1 guidelines. The method demonstrated. The method demonstrated system precision, specificity, precision at the limit of quantitation (LOQ), accuracy, solution stability, linearity, ruggedness and robustness. The HPLC conditions consisted of a mobile phase composed of pH 4.50 buffer and methanol in a ratio of 70:30 (v/v)-mobile phase A and 35:65 (v/v)-mobile phase B with a flow rate of 1.2 mL/min and UV detection at 216 nm for Butalbital, Acetaminophen and Caffeine, 254 nm for Methylparaben and Propylparaben. The entire chromatography run time was 16 minutes. Linearity was established over a concentration range of 40%-160% with a correlation coefficient of more than 0.995. Accuracy was confirmed within the range between 50% and 120%. This validated HPLC method is suitable for the precise quantification of Butalbital, Acetaminophen, Caffeine Oral Solution 50mg/325mg/40mg per 15 mL and Preservatives-Methylparaben and Propylparaben, making it an effective method for quality control and assurance in pharmaceutical manufacturing.