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ISSN 2063-5346
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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF METHYLCOBALAMIN BY UFLC IN ORAL SOLID DOSAGE FORMS

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G. Deepthi, D Naveen Kumar, P Vinodh, Darla Laharika, Tallaka Bhuvaneswari, Shaik , P.K. Prakash Reddy
» doi: 10.53555/ecb/2024.13.03.17

Abstract

Methylcobalamin Tablets are available in the market. But the literature review reveals that there is no official monograph for Methylcobalamin Tablets in Indian Pharmacopoeia and also no analytical method reported for the analysis of Methylcobalamin by UFLC in oral solid dosage form. Spectrophotometer and RP-HPLC are the reported analytical methods for compounds either individually or in combination with other dosage form. Hence, it was felt that, there is a need of new analytical method development for the estimation of Methylcobalamin by UFLC in oral solid dosageform. Present work is aimed to develop a new, simple, fast, rapid, accurate, efficient and reproducible Liquid Chromatography method for the analysis Methylcobalamin by UFLC in solid dosage form. The developed method will be validated according to ICH guidelines. Retention time of Methylcobalamin was found to be 1.193min. and the regression equation of Methylcobalamin is y=0.0000x-0.1035 &r²=0.9999. The Method precision is 0.73%, Intermediate precision for day 01 is 052% and the intermediate precision for Day 02 is 0.55% The assay of Methylcobalamin found as 100.21%.Since the Retention time of Methylcobalamin is less than 2.0 minutes, the developed method is cost effective with short analytical time. So the method developed was simple and economical that can be adopted in regular Quality control test inIndustries.

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