Method Development for Identification of Manidipine HCl using High Performance Liquid Chromatography

Author: Jadhav A.B. Nawale R.B. and Thorat S.T.

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Abstract

Manidipine HCl (MND) is a third-generation dihydropyridine calcium (Ca) channel antagonist that is lipophilic and highly selective for the vasculature, leading to significant peripheral vasodilation and minimal cardio depression. MND appears to increase insulin sensitivity without altering metabolic function and helpful in hypertensive individuals with comorbidities such as type 2 diabetes mellitus and/or renal impairment. MND is a first-line medication for people with essential mild-to-moderate hypertension as a result. The discovery, development, and production of pharmaceuticals depend heavily on the development and validation method, among all HPLC is one of them due to its very effective separations and often high detection sensitivity, HPLC is the most widely used separation method in contemporary pharmaceutical and biomedical analysis. Its numerous benefits, includes its speed, specificity, accuracy, precision, and ease of automation, the majority of medications in multi-component dosage forms can be examined using this technique. The development and validation of HPLC procedures are crucial to novel discoveries, the creation of pharmaceutical medications, and numerous other human and animal investigations. This study provides details on the various steps that go into developing and validating a HPLC technique for MND. According to ICH Guidelines, its include testing for system appropriateness as well as accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness, and other performance characteristics. The developed HPLC method effectively identified and quantified Manidipine HCl, including impurities, with reliable results

Keywords

Manidipine HCL (MND), Identification, Validation, High Performance Liquid Chromatography (HPLC), Method development

Conclusion

HPLC method development presented in this study shows that this method is suitable for the identification of Manidipine HCL. An HPLC method for the identity, assay, and purity evaluation of Manidipine HCL and its impurities has been successfully developed. Study has demonstrated that the method is rugged. It has also been extensively validated

References

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How to cite this article

Jadhav A.B., Nawale R.B. and Thorat S.T. (2023). Method Development for Identification of Manidipine HCl using High Performance Liquid Chromatography. Biological Forum – An International Journal, 15(6): 957-965