Original Articles: 2025 Vol: 17 Issue: 1
Analytical Method Development and Validation for Simultaneous Estimation of Valsartan and Lisinopril in Bulk and Tablet Dosages Form Using HPLC
Abstract
Objective: The purpose of gift examines became to increase an analytical method and validation for the simultaneous estimation of valsartan and lisinopril in bulk a pill dosage form and to make sure the pleasant precision and accuracy via the use of HPLC as well as to increase a manner that can be carried out for the habitual evaluation in laboratories and in-house approach for analysis. Introduction: Analytical approach validation is the method of demonstrating that the analytical strategies are suitable for their intended use. according to FDA tenet, analytic technique validation is an issue of setting up documented proof that gives an excessive diploma of guarantee that the desired approach will always offer accurate check consequences that evaluate a product in opposition to its described specification and nice attributes. Analytic methods are intended to set up the identity, purity, bodily characteristics and potency of the medicine that we use. Analytical strategies are required to represent drug substance and drug product composition during all phases of pharmaceutical improvement. Materials and Methods: Analytical method improvement and validation were performed by using the usage of reverse section HPLC. Separation of the drug was achieved on a opposite phase C8 column using a cell segment including phosphate buffer and methanol in the ratio of 35:65 v/v. The drift rate become 0.8 mL/min and the detection wavelength became 237 nm. Usual analytical performance characteristics that were considered inside the validation of the kind of approach are specificity, linearity, accuracy, precision, LoD, LoQ, robustness and gadget suitability. Results: The peaks were discovered by way of a UV-detector at 237 nm and the retention time for each the medication changed into 2.664 and 3.423 min. the percentage restoration became 99-100% for both the medication. Technique validation was executed for all above new methods evolved. Linearity parameter for the method became analysed with the aid of making ready answer of 5 stages of concentrations. Calibration curve for concentration versus height regions changed into located linear. Precision changed into studied with the aid of getting ready solutions in six replicates and analyzed, % RSD become calculated for the peak regions of every drug. Accuracy for new techniques advanced, evaluated through using the standard solutions of three specific concentrations (50%, 100% and 150%) into sample answer and their percentage recovery at each stage become decided. Robustness for above methods became completed at exclusive go with the flow prices and at one-of-a-kind organic composition, preferred and sample answers have been organized and analyzed at +0.1 ml/min and at +10% and advanced method located to be solid on planned variation. Conclusion: Parameters evaluated for validating novel RP-HPLC strategies for improvement of analytical method and validation for the simultaneous determination of above dosage paperwork meet the necessities of ICH pointers. The developed techniques are easy, particular, cost effective and fast. These newly