A SENSITIVE AND A SIMPLE RP-HPLC METHOD DEVELOPMENT AND VERIFICATION FOR THE QUANTITATIVE ESTIMATION OF CHOLECALCIFEROLIN TABLETS

K. SUBHASHINI; U. TRIVIKRAM NAIDU; A. ASHOK KUMAR; RAJESH VOOTURI; N. VENU KUMAR

doi:10.22159/ijcpr.2023v15i6.3097

Authors

K. SUBHASHINI Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India
U. TRIVIKRAM NAIDU Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India
A. ASHOK KUMAR Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India
RAJESH VOOTURI Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India
N. VENU KUMAR Formulation AR and D, Aurigene Pharmaceutical Services Limited, Hyderabad, Telangana, India

DOI:

https://doi.org/10.22159/ijcpr.2023v15i6.3097

Keywords:

RP‐HPLC, Cholecalciferol, Analytical Method development, Tablets

Abstract

Objective: To develop a sensitive, simple, accurate, precise and linear Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method and verify for the quantitative estimation (Assay) of Cholecalciferol in tablets.

Methods: The optimized method uses a reverse phase column, Waters X-Bridge C8 (150 X 4.6 mm; 3.5μ), a mobile phase of Methanol: Acetonitrile: HPLC grade water/Milli-Q water in the proportion of 60:30:10 v/v/v, flow rate of 0.8 ml/min, injection volume of 100 µl, and detection wavelength of 265 nm using a UV/PDA detector.

Results: The developed method gave Cholecalciferol eluting at about 9 min. Cholecalciferol exhibited linearity in the range 0.058-0.466 μg/ml. The precision is exemplified by a relative standard deviation of 1.40%. Percentage of individual recovery was found to be in the range of 97.0 and 103.0 during accuracy studies.

Conclusion: A sensitive, simple, accurate, precise and linear RP-HPLC method was developed and verified for the quantitative estimation (Assay) of Cholecalciferol in tablets and hence this method can be explored for the analysis of Cholecalciferol in tablets/various dosage forms in various pharmaceutical industries.

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