Method development and validation of mecobalamin injection by uv-spectrophotometer

Muhammad Aslam; Asad Gulzar; Amina Asghar; Misbah Irshad; Samreen Kausar; Umair Ahmad; Zahra Noreen; Abrar Hussain; Rashad Mehmood

An efficient, accurate, simple, fast, precise and reproducible UVspectrophotometric method was developed using pH-7.0 buffer (monobasic potassium dihydrogen phosphate) for the validation of mecobalamin injection. The standard 20 µg/mL solution was scanned between the range of 200 - 600 nm and ?max was found to be 522 nm. Validation parameters were checked for the developed method as per ICH guidelines. The linearity concentration range 16 - 24 µg/mL showed that it obeyed Lambert's law and the developed method was linear with a good correlation coefficient. Standard addition method was performed for the proposed method and percent recovery studies revealed that the developed method was accurate. Percent relative standard deviation (RSD) value was calculated for precision studies which showed that the developed method was highly precise. The established method was validated in terms of linearity, precision, intermediate precision, accuracy, robustness and ruggedness. The results of all these parameters significantly showed that the developed method can be used for the routine validation of mecobalamin injection in pharmaceutical laboratories.