World Journal of
Pharmaceutical and Life Sciences

HPLC METHOD DEVELOPENT AND VALIDATION FOR THE ESTIMATION OF PROPRANOLOL AND FLUNARIZINE IN COMBINED DOSAGE FORM

Siraj Ahamad* and Dr. N. K. Sahu

ABSTRACT

Aim: The aim of this study is to develop and validate a high-performance liquid chromatography (HPLC) method for the simultaneous estimation of Propranolol and Flunarizine in a combined dosage form. The developed method aims to provide a reliable, accurate, and efficient means of quantifying both drugs in the pharmaceutical formulation. Method Development: To optimize chromatographic conditions for the separation of Propranolol and Flunarizine. To select a suitable stationary phase, mobile phase composition, and gradient elution program for efficient separation. To achieve baseline resolution and adequate peak shapes for both compounds. Method Validation: To validate the developed HPLC method according to regulatory guidelines. To evaluate the specificity of the method by ensuring that excipients or other potential impurities do not interfere with the detection of Propranolol and Flunarizine. To establish linearity over a range of concentrations for both Propranolol and Flunarizine. To determine the precision of the method, including repeatability, intermediate precision (day-to-day and analyst-to-analyst variations), and reproducibility. To assess the accuracy of the method by conducting recovery studies on the combined dosage form. To establish the limits of detection (LOD) and quantification (LOQ) for both Propranolol and Flunarizine. Conclusion: Modern medicines for human use are required to comply with specific standards and regulation set forth by the concerned authorities. The efficacy and safety of medicinal products can only be assured by analytical monitoring of its quality. Pharmaceutical analysis is an art and science of determining the concentration of drug constituents present in marketed formulation. It is considered as an application of procedures necessary to determine and estimate the identity, strength, quality and purity of drug. Therefore, the quality control laboratory is considered as the backbone of the pharma industries with ever- increasing need for the development of analytical techniques for drug formulation.

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