Application of RP–HPLC method in dissolution testing and statistical evaluation by NASSAM for simultaneous estimation of tertiary combined dosages forms

Abstract

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.

Thermodynamic Solubility Profile of Carbamazepine–Cinnamic Acid Cocrystal at Different pH

“…In this study, to calculate thermodynamic solubility of drugs, NASSAM method was applied to simultaneous determination of CBZ and CIN concentration in solution for the first time. These findings confirm the previous study that chemometrics‐based methods (such as UV‐NASSAM and UV‐multivariate calibration approaches) could be used instead of time‐consuming and expensive separation‐based method, that is, HPLC for the quantification of each component in dissolution medium in multicomponent systems such as cocrystals, coamourphous systems, and combined dosages forms …”

In Vitro Study to Evaluate the Efficacy of Ultrasonicated Ethanolic Extract of Rosmarinus officinalis and its Chitosan-Based Nanoparticles Against Eimeria tenella Oocysts of Chickens

“…As indicated by HPLC chromatogram of this study, caffeic and rosmarinic acids in UEERO-CsNPs3 were separated at retention time of 3.41 and 11.22 min, respectively while in UEERO-CsNPs5, they were observed at retention time of 3.80 and 11.32 min, respectively. This reveals that both acids were repeatedly retained in UEERO-CsNPs3 and UEERO-CsNPs5, stating very good resolution for both acids [70]. Consequently, the total LE of UEERO particles on CsNPs5 and CsNPs3 calculated according to Espinoza et al [42] using UV-vis spectrophotometer was about 80.05 and 64.39%, respectively that may be due to the enhanced positive charge of NPs.…”