DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH


Manish Kumar, Ajay Kumar Shukla, Ram Singh Bishnoi, C. P. Jain

Abstract


Objective: To develop a simple, rapid, accurate, robust and inexpensive spectrophotometric method for the estimation of benidipine hydrochloride by using quality by design (QbD)โ€ approach.

Methods: A UV spectrophotometric method was developed on Shimadzu UV-1800 double beam spectrophotometer using methanol as solvent and wavelength of 236 nm was selected as absorbance maxima (๐œ†max). Effect of input variables on spectrum characteristics were studied for the selection of critical parameters and proposed method was validated for various parameters like system suitability, linearity, precision, accuracy, detection limits and quantification limits as per the International Conference on Harmonization guidelines ICH Q2(R1).

Results: Linearity of the method was found to be excellent over the concentration range 3 to 18 ยตg/ml with high correlation coefficient value of 0.9999. Limits of detection and quantification were found to be 0.20 ยตg/ml and 0.60 ยตg/ml respectively. The mean recovery was found to be 100.35 % with low percentage relative standard deviation (% RSD) value. The precision study also has shown low % RSD value (<1). No interfering peaks were observed during specificity studies.

Conclusion: Obtained result indicated that the developed spectrophotometric method is robust and efficient for the determination of benidipine hydrochloride.


Keywords


Quality by design, Analytical quality by design, Benidipine hydrochloride estimation, Analytical method validation, Spectrophotometric estimation

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About this article

Title

DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH

Keywords

Quality by design, Analytical quality by design, Benidipine hydrochloride estimation, Analytical method validation, Spectrophotometric estimation

DOI

10.22159/ijap.2018v10i4.26623

Date

07-07-2018

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 10, Issue 4 (July-Aug), 2018 Page: 92-97

Online ISSN

0975-7058

Authors & Affiliations

Manish Kumar
Department of Pharmaceutical Sciences, Mohanlal Sukhadia University, Udaipur, Rajasthan, India
India

Ajay Kumar Shukla
Department of Pharmaceutical Sciences, Mohanlal Sukhadia University, Udaipur, Rajasthan, India
India

Ram Singh Bishnoi
Department of Pharmaceutical Sciences, Mohanlal Sukhadia University, Udaipur, Rajasthan, India
India

C. P. Jain
Department of Pharmaceutical Sciences, Mohanlal Sukhadia University, Udaipur, India
India


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