ANALYTICAL METHOD DVELOPMENT AND VALIDATION OF EFONIDIPINE HYDROCHLORIDE ETHANOLATE IN BULK AND DOSAGE FORM BY UV-VISIBLE SPECTROPHTOMETRY

ANALYTICAL METHOD DVELOPMENT AND VALIDATION OF EFONIDIPINE HYDROCHLORIDE ETHANOLATE IN BULK AND DOSAGE FORM BY UV-VISIBLE SPECTROPHTOMETRY
Author(s):
Raviraj N. Jalkote, Manisha S. Kaulage, Pallavi N. Kshirsagar, Bahar W. Khan, Pooja S. Mane, Gayatri V. Kuber
Keywords:
Efonidipine, UV Spectrophotometry, Absorbance maxima, Method validation.
Abstract
A simple, precise, accurate, economical and reliable UV Spectrophotometric method has been developed for the estimation of Efonidipine in tablet dosage form. The drug shows maximum absorption at 253 nm in methanol and obeys Beer’s law in the concentration range of 10-30 μg /mL with good correlation coefficient (R2=0.997). The results of analysis were validated by recovery studies. The recovery was found to be 96-99 %. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 2.82 μg/ml and 8.57μg/ml respectively. The relative standard deviation was found to be < 2.0 % in all cases. The Proposed Spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The proposed method can be used for the reliable quantification of Efonidipine in bulk form and routine analysis of pharmaceutical formulations.
Article Details
Unique Paper ID: 155400 Publication Volume & Issue: Volume 9, Issue 1 Page(s): 838 - 843
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