Development of validated stability indicating method for estimation of vandetanib and characterization of its degradants by LC-ESI-MS
Salode, Vikrant Liladhar
Development of validated stability indicating method for estimation of vandetanib and characterization of its degradants by LC-ESI-MS - Vol.56(1), Jan-Mar - Karnataka Association of Pharmaceutical Teachers of India (APTI) 2022 - 232-239p.
Aim: In the current study, stability indicating high performance liquid chromatography
method (RP-HPLC) was developed and validated for the determination of Vandetanib,
also its major degradants were identified and characterized by Liquid Chromatography-
Tandem Mass spectrophotometric method (LC-ESI-MS). Methods and Materials: This
method was developed on Nucleosil 100-5, C18 (250×4.6 mm, 5μm) column by using
Methanol: Ammonium acetate buffer as Mobile phase in the ratio, 90:10 v/v, having flow
rate of 1 ml/min. The estimation was carried out at 249 nm. Further Vandetanib was
subjected to various stress condition like acidic, alkali, oxidative, thermal and photolytic
degradation. The degradation pathways for major degradants were idenitifed. Results:
The method was developed and validated for linearity, robustness, accuracy, precision,
linear regression analysis data which indicates the good linear relationship, correlation
coefficient was found 0.992 in the concentration range of 1-10 μg/ml. In the stress
results, the degradation of drug in alkaline, as well as acidic medium showed significantly.
The product degradation was characterized by the LC-MS technique. Conclusion: The
developed method was found to be rapid, sensitive, accurate, precise, and robust for the
analysis of Vandetanib by which routine analysis of drugs can be done.
PHARMACEUTICS
Development of validated stability indicating method for estimation of vandetanib and characterization of its degradants by LC-ESI-MS - Vol.56(1), Jan-Mar - Karnataka Association of Pharmaceutical Teachers of India (APTI) 2022 - 232-239p.
Aim: In the current study, stability indicating high performance liquid chromatography
method (RP-HPLC) was developed and validated for the determination of Vandetanib,
also its major degradants were identified and characterized by Liquid Chromatography-
Tandem Mass spectrophotometric method (LC-ESI-MS). Methods and Materials: This
method was developed on Nucleosil 100-5, C18 (250×4.6 mm, 5μm) column by using
Methanol: Ammonium acetate buffer as Mobile phase in the ratio, 90:10 v/v, having flow
rate of 1 ml/min. The estimation was carried out at 249 nm. Further Vandetanib was
subjected to various stress condition like acidic, alkali, oxidative, thermal and photolytic
degradation. The degradation pathways for major degradants were idenitifed. Results:
The method was developed and validated for linearity, robustness, accuracy, precision,
linear regression analysis data which indicates the good linear relationship, correlation
coefficient was found 0.992 in the concentration range of 1-10 μg/ml. In the stress
results, the degradation of drug in alkaline, as well as acidic medium showed significantly.
The product degradation was characterized by the LC-MS technique. Conclusion: The
developed method was found to be rapid, sensitive, accurate, precise, and robust for the
analysis of Vandetanib by which routine analysis of drugs can be done.
PHARMACEUTICS