DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR DETERMINATION OF CALCIUM OROTATE IN BULK AND TABLET DOSAGE FORM

MD. Saiful Islam*, MD. Taleb Hossain, Sukalyan Kumar Kundu, Maksuda Akter and MD. Rafiquzzaman

ABSTRACT

Calcium implicates normal functioning of nerves, cells, muscle, and bone. Deficiencies of calcium results in uptake of calcium from bones, thereby weakening bones. A simple, sensitive and highly accurate UV spectroscopic method has been developed for the determination of Calcium Orotate in bulk and its tablet dosage form. Calcium Orotate in its water solutions was determined at the wavelength range of 240-400 nm by the spectroscopic method. Solution of Calcium Orotate in water shows a maximum absorbance at 278 nm. Beer’s law was obeyed in the concentration of 4-12 μg.mL-1. Correlation coefficient, detection and quantification limit were also calculated. The proposed method has been applied successfully to quantify of Calcium Orotate in pure and tablet dosage form. Results of percentage recovery and placebo (excipients) interference show that the method was not affected by the presence of common excipients. The percentage of recovery of Calcium Orotate in tablet was 99.25-101.25% of the label claimed 400 mg per tablet. The method was then validated successfully as per ICH guidelines (2005) which yielded good results concerning range, precision, accuracy, reproducibility, specificity and robustness.

Keywords: Calcium Orotatetablets, Potency, UV-Spectroscopic method, Estimation, Method validation.