Spectrophotometric Method Development and Validation for the Estimation of Mesalazine in Pure and Tablet Dosage Form by UV- Spectrophotometric Method

Author(s)

Rao, R. N., Reddy, L. S., Reddy, E. P., Ravisankar, V., Sulakshana, S.

Author's Affiliation

Abstract

The objective of the present research work is to develop a simple, accurate, precise and sensitive spectroscopic method was developed for the estimation of Mesalazine in the pure and tablet dosage forms. A simple, rapid and accurate analytical method was developed for the estimation of Mesalazine in bulk and tablet dosage form by UV spectrophotometer and validated for the parameters like linearity, accuracy, system precision, intra-day precision, inter-day precision/ intermediate precision/ ruggedness, robustness, limit of detection (LOD) and limit of quantification (LOQ) as per ICH Guidelines. The melting point of Mesalazine (283º C) was recorded to check the identification of the drug. After considering the solubility, 6.8 phosphate buffer was selected as solvent. Mesalazine, 10 μg/ml solution was prepared and scanned in the UV region, from the spectra 330 nm was selected as an analyzing wavelength. Stability of the absorbance at λmax 330 nm was also checked for up to 2 hours and 30 minutes. The optical characteristics such as absorption maxima (nm), beer’s law limits (μg/ml) and correlation coefficient (r) were calculated for the method. The analysis of the tablet formulation by proposed method was in good agreement (401 ± 0.4956 mg/tablet) with label claim. The recovery studies were carried out at three different levels, i.e. 120%, 100% and 80%.The low value of % RSD is indicative of the accuracy of the proposed method. The result of recovery study revealed that the commonly encountered excipients and other additives usually present in the dosage form did not interfere with the proposed method. The precision of the proposed method was studied as an intra-day and inter-day analysis. The results obtained in recovery studies will indicate that there is no interference from the excipients used in the formulation.The developed method was validated as per ICH guidelines and was found to be accurate and precise. Thus the proposed method can be successfully applied for the estimation of Mesalazine in pure and tablet dosage form.

Keywords

Mesalazine, UV- Spectrophotometry, Tablet formulation, Validation

Cite This Article

Rao, R. N., Reddy, L. S., Reddy, E. P., Ravisankar, V., Sulakshana, S. & Meenakshi, R. (2015). Spectrophotometric Method Development and Validation for the Estimation of Mesalazine in Pure and Tablet Dosage Form by UV- Spectrophotometric Method, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(4), 88-92.