Simultaneous determination of cinnarizine and domepiridone maleate from tablet dosage form by reverse phase ion pair high performance liquid chromatography

1999 ◽  
Vol 19 (6) ◽  
pp. 813-817 ◽  
Author(s):  
A.P Argekar ◽  
S.J Shah
Author(s):  
Ramreddy Godela ◽  
Sherisha Bhavani

Objective: The most important objective of the present research work is to develop simple, specific, rapid, accurate, and sensitive reverse-phase high-performance liquid chromatography method and validated for the qualitative and quantitative determination of valsartan in its active pharmaceutical ingredient and tablet dosage form according to ICH guidelines.Proposed Method: An isocratic separation was done using Phenomenex C18 column possess 75×4.6 mm, 2.6 μ,100 A0 dimensions with mobile phase composition of water:acetonitrile (30:70% v/v) by maintaining 1 ml/minute flow rate and response detected at a wavelength of 247 nm.Results: The retention time of valsartan was found to be 2.71 minutes, limit of detection and limit of quantification were observed at 1.24 μg/ml and 3.6 μg/ml concentration, respectively, and a calibration curve was linear in the concentration range of 5-50 μg/ml with coefficient of correlation 0.99. The percentage recovery (accuracy) was in the range of 98.9-102%, and the % relative standard deviation was observed to be <2%.Conclusion: The proposed method was validated for accuracy, precision, sensitivity, linearity, and robustness and successfully employed for the quantitative determination of valsartan in tablet dosage form in quality control department of pharmaceutical industry.


2021 ◽  
Vol 18 (10) ◽  
pp. 2161-2166
Author(s):  
Madhusudan T. Bachute ◽  
Sunil V. Shanbhag ◽  
Shankar L. Turwale

Purpose: To develop a single, low-cost and rapid analytical method for the simultaneous determination of four active components - chlorpheniramine maleate, paracetamol, phenylephrine hydrochloride and caffeine – in a tablet dosage form. Method: This method was based on reverse-phase high performance liquid chromatography (RPHPLC) and involved the use of a C-18 column (250 × 4.6 mm, 5.0 μm), a mobile phase consisting of buffer solution and methanol at a flow rate of 1.00 mL/min, and gradient determination with UV detection at 220 nm. Results: Retention time was 4.33, 10.36, 13.85, and 17.35 min for phenylephrine hydrochloride, paracetamol, caffeine, and chlorpheniramine maleate, respectively. Specificity data showed no interference from the excipients, and accuracy of the method was close to 100 %. The method was validated as per the guidelines of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and all the results met the acceptance criteria for accuracy, precision, linearity, specificity, limit of quantitation, limit of detection, and robustness. Conclusion: This method can successfully perform quantitative assessment of phenylephrine HCl, chlorpheniramine maleate, paracetamol, and caffeine in tablet combination dosage forms faster and more cost-effectively than conventional methods.


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