Asian Journal of Pharmaceutical Research

K. Vijaya Sri ¹, S. Sravani ¹, M. Shiva Kumar ¹

Affiliations
1 Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, Secunderbad, Telangana, IN

Abstract

The UV-spectroscopic method were developed and validated for the estimation of Lurasidone HCl as per ICH guidelines. A simple, fast, accurate and precise UV-spectroscopy method was developed by using methanol: water (70:30v/v) and acetonitrile: water (50:50v/v) was used as the solvent in both methods. The λ_max of Lurasidone was found to be 230 nm and it was proved linear in the concentration range of 2.5-15 μg/ml with a correlation coefficient value of 0.999 for both the methods. The accuracy studies of UV-spectroscopy method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 99.2 to 102.4% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.61-0.69 for both UV Method. The % RSD is <2% which indicates the accuracy and precision of the method.

Keywords

Lurasidone, Validation, Estimation, UV Spectrophotometry, Methanol: Water and Acetonitrile: Water.

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K. Vijaya Sri ¹, R. Harish Kumar Reddy ¹, R. Mahesh ¹

Affiliations
1 Malla Reddy College of Pharmacy, Maisammaguda, Secunderabad, Andhra Pradesh, IN

Abstract

The purpose of this research was to make an attempt to develop mouth dissolving tablets of diphenhydramine hydrochloride. Mouth dissolving tablet offers a solution for pediatrics, adolescents and geriatrics patients those have difficulty in swallowing tablets/capsules, resulting in improved patient compliance. Diphenhydramine is used as anti emetic, anti tussive for dermatosis and pertusis and for hypersensitivity reactions. The aim is to formulate different formulations of mouth dissolving tablets of diphenhydramine hydrochloride using different superdisintegrants like crospovidone and croscarmellose sodium and subliming agent menthol, by direct compression and sublimation method. Precompression parameters were characterized for flow properties and prepared tablets were evaluated for hardness, thickness, friability, weight variation, wetting time, water absorption ratio, drug content, disintegration time and dissolution studies. In vitro dissolution studies show that release in tablets with a combination of superdisintegrant and subliming agent was good. Among all the formulations, F9 (10% crospovidone and menthol)showed maximum drug release of 99.76% in 12min. Hence it is evident from this study that mouth dissolving tablets could be a promising delivery system for diphenhydramine hydrochloride with good mouth feel and improved drug bioavailability with better patient compliance.

Keywords

Mouth Dissolving Tablet, Super Disintegrants, Subliming Agent, Diphenhydramine Hydrochloride, Direct Compression, Sublimation.

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