A dissolution method with robust high performance liquid chromatographic (HPLC) analysis for immediate release tablet formulation was developed and validated to meet the requirement as per International Conference on Harmonization (ICH) and United States Food and Drug Administration (USFDA) guidelines. The method involved the use of Agilent ZORBAX Eclipse XDB C18 column, and temperature was maintained at 30 °C. After optimization, the mobile phase was selected as phosphate buffer (KH2PO4, 30 mM) : ACN (60:40, v/v) with pH 3.0, and retention time Rt was found as 3.24, 4.16, and 2.55 min for paracetamol (PCM), chlorpheniramine maleate (CPM) and phenylephrine hydrochloride (PH) respectively at 265 nm and at a flow rate of 1 mL/min. The relative standard deviation (%RSD) for 6 replicate measurements was found to be less than 2%. Furthermore net analyte signal standard addition method (NASSAM) with spectrophotometer was performed for standard and liquid oral suspension. On the basis of selectivity, sensitivity and accuracy analysis, it was confirmed that this novel method could be useful for simultaneous estimation of the given drug combinations. Two-way analysis of variance (ANOVA) was applied for evaluating the statistical difference between the assay results obtained via both NASSAM and RP–HPLC methods and ultimately no significant difference was found between both the methods. All the methods and results were acceptable and confirmed that the method was suitable for intended use.
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).
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