DEVELOPMENT AND VALIDATION OF AN ACCURATE, SENSITIVE AND REPRODUCIBLE RP–HPLC METHOD FOR THE ESTIMATION OF VITAMIN D3 IN PHARMACEUTICAL DRUGS AND CONFIRMATION OF THE RESULTS BY UV/VIS–SPECTROPHOTOMETRY

J.C. Pradeep Kumar; Ranjana Bhadane; Nilesh Yeole

Volume : VII, Issue : VI, June - 2017

DEVELOPMENT AND VALIDATION OF AN ACCURATE, SENSITIVE AND REPRODUCIBLE RP–HPLC METHOD FOR THE ESTIMATION OF VITAMIN D3 IN PHARMACEUTICAL DRUGS AND CONFIRMATION OF THE RESULTS BY UV/VIS–SPECTROPHOTOMETRY

J. C. Pradeep Kumar, Ranjana Bhadane, Nilesh Yeole

Abstract :

A rapid, simple, sensitive isocratic reproducible reversed phase HPLC technique has been developed for the quantitative assay evaluation of Vitamin D3 in various pharmaceutical drugs. The Chromatographic separation of Cholecalciferol samples were performed on a C18–column by isocratic elution at the column at 30 °C. The Mobile Phase used was methanol. The flow rate was 1ml/min. The maximum area was resolved at 250.0 nm by using UV/Vis photometric detector. The caliation curve was found to be in the range 10 ppm to 50 ppm with regression coefficient 0.9804. The % recovery for D3 MUST tablet was 105% respectively by HPLC technique. The above results have also been verified by UV/Vis– spectrophotometry technique within limits of ±10% error. The method was validated to determine the accuracy and precision by performing recovery studies. The proposed method can be successfully used to quantify the amount of Vitamin D3 in formulated drugs.