Simultaneous Estimation and Statistical Evaluation of Developed Validated Methods for Combined Drugs in Marketed Formulation

Abstract

We have developed rapid derivative methods for simultaneous estimation of paracetamol (PCM), chlorpheniramine maleate (CPM), and phenylephrine hydrochloride (PH) in pure and liquid dosage form. All methods are simple, accurate, rapid, precise, economical and reliable. Methods are third derivative zero crossing spectrophotometry (I), single divisor ratio spectra derivative spectrophotometry (II), double divisor ratio spectra derivative method (III) and Vierdot's method (IV). All the method utilizes methanol: 0.1N hydrochloric acid (1:9). For method I, II, III and IV Limit of Detection (L.O.D.) values were within 0.59-1.37 µg/mL, 0.60 -3.72 µg/mL and 0.71-3.22 µg/mL respectively; and Limit of Quantification (L.O.Q.) values were within 1.83-4.40 µg/mL, 2.11-11.91 µg/mL and 2.32-10.70 µg/mL for PCM, CPM and PH respectively. The linearity ranges for PCM, CPM and PH were found to be 1.5-15µg/mL, 5-40 µg/mL and 9-64 µg/mL respectively, showing regression coefficient values 0.999 < R 2 <1. Precision values were found less than 2% Relative Standard Deviation (R.S.D.) for all methods. The results obtained have been compared statistically via analysis of variance (ANOVA).