Accelerated Stability Indicating: Method Development of UV-visible Spectrophotometric Analysis and its Validation for Vitamin-D3 Estimation in Tablets

Abstract

Purpose: A facile approach to develop and validate an precise  accurate, and stable method over UV-visible spectrophotometer (UV-vis) for Vitamin D3 (VD3) tablets. Methods: In this study, three brands of VD3 tablets from various companies were employed. UV-vis was used to test the short term stability research of vitamin D3. In short-term stability research, an assay of vitamin D3 is evaluated on UV-vis after one month of their manufacturing that is known as zero month then after 3 months and lastly after 6 months. Conditions of short term stability study for six months consists of temperature 40 °C within upper-lower limit of 2 % and moisture content of 75 % within upper-lower limit of 5 %. For identification of VD3 in tablet dosage form, a simple UV-vis procedure was formulated that had an appropriate susceptibility according to accuracy, precision, and linearity. Guidelines of International Council of Harmonization of technical requirements for pharmaceuticals of Human use and United States Pharmacopeia were followed for validation of these parameters. Results:  Out of three brands, one brand of vitamin D3 (VD3) tablet dosage form by UV-vis method was found to be stable at the appropriate temperature and moisture content in comparison to other two brands of VD3 that started to lose their efficiency at elevated temperature and moisture content from the normal range. VD3 shows it’s absorbance in deionized water at the wavelength of 265 nm, linearity range of 0.65-9.94 µg ml^-1, molar absorptivity of 4.32 x 10⁴ L/molcm^-1 with a correlation coeffeicient equation  of y=0.0503×-0.4988 and regression of R²= 0.9991. Conclusion: It was found that VD3 demonstrated the best result in climate atmosphere as compared to an accelerated parameters which lead to the breakdown of VD3 when tested witht the help of UV-vis method.