Open AccessQuantification and Stability Indicating Method Development and Validation of Vismodegib in Bulk and Pharmaceutical Dosage Form by Ultra Performance Liquid Chromatography
Author(s) -
V. Mohan Goud,
Marti Harini,
CH. B. Praveena Devi,
M. Meghana Goud
Publication year - 2021
Publication title -
journal of pharmaceutical research international
Language(s) - English
Resource type - Journals
ISSN - 2456-9119
DOI - 10.9734/jpri/2021/v33i59a34340
Subject(s) - repeatability , chromatography , diluent , vismodegib , high performance liquid chromatography , materials science , analytical chemistry (journal) , chemistry , biochemistry , nuclear chemistry , hedgehog , gene
Background: Vismodegib (VMD) is a drug of choice for the treatment of basal-cell carcinoma. Present studies carried out to estimate VMD by RP-UPLC technique and to develop a simple, précised, accurate method for routine analysis.
Methods: For this purpose Chromatographic conditions used were stationary phase STD BEH C18 column (100 mm x 2.1 mm, 1.8m), a mixture of Methanol:KH2PO4 taken in the ratio 50:50%v/v as a mobile phase with a pH 7.4 and flow rate was maintained at 0.3ml/min, detection wave length was Acquity TUV 254nm, column temperature was set to 30oC and diluent was mobile phase, Conditions were finalized as optimized method.
Results: System suitability parameters were studied by injecting the standard six times. Linearity study was carried out between 25% to150% (37.5-225µg/ml) levels, R2 value was found to be as 0.9992. Precision was found to be 0.6 for repeatability and 0.4 for intermediate precision. LOD and LOQ are 0.33 µg/ml and 0.99 µg/ml respectively and results were well under the acceptance criteria.
Conclusion: By using above method assay of marketed formulation was carried out and was found 100.12%. Degradation studies of VMD were done, in all conditions purity threshold was more than purity angle and within the acceptable range. The developed method was simple and can be used for routine analysis.