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Asian Journal of Pharmacy and Technology
Year : 2019, Volume : 9, Issue : 2
First page : ( 89) Last page : ( 92)
Print ISSN : 2231-5705. Online ISSN : 2231-5713.
Article DOI : 10.5958/2231-5713.2019.00015.1

Analytical Method Development and Validation for the Determination of Ivabradine HCl by RP-HPLC in bulk and Pharmaceutical Dosage form

Thete Prajakta Gopinath1,*, Saudagar Ravindranath Bhanudas2

1Department of Quality Assurance Techniques. R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

2Department of Pharmaceutical Chemistry. R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

*Corresponding Author E-mail: prajaktathete95@gmail.com

Online published on 3 July, 2019.

Abstract

Purpose

A simple, rapid, highly sensitive, selective, specific, robust RP-HPLC method has been developed and validated for the estimation of Ivabradine HCL in bulk and pharmaceutical dosage form.

Methods

The Chromatographic separation was obtained using a mobile phase Methanol: ACN (80: 20 v/v) on Zorbax EclipsPlus C18 (250mm×46mm, 5.0μ) at 30℃ with UV detection 286 nm at flow rate 1ml/min. The linearity was found to be 2.5–50μg/ml. The retention time was found to be 5.8 min.

Results

The method was validated according to ICH. The correlation coefficient (r2) of HPLC method was found to be 0.9998. The LOD and LOQ were found to be 0.0216μg/ml and 0.06537μg/ml respectively. The intra-day and inter-day precision and accuracy values for method were found to be ˃2% RSD.

Conclusion

The ProposedRP-HPLC method has been successfully applied to the commercial tablets without any interference of excipients. The method can be used for the routine analysis in industry forIvabradine HCLin bulk and tablet dosage forms.

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Keywords

Ivabradine HCL, RP-HPLC, Pharmaceutical Dosage forms, Mobile Phase, ICH, Validation.

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