Mohammad Mojeeb Gulzar Khan

Abstract

For the determination of pimvanserin tartrate in bulk and formulation, a rapid and simple High Performance Thin Layer Chromatography at 226 nm was developed and validated. The determination was carried out on thin coated aluminum backing plates covered with 200 mm layer of silica gel G 60 F254 (10×10 cm) plate as stationary phase and using a mobile phase of methanol: chloroform: trimethylamine (4:6:0.1 v/v/v) respectively. With a correlation coefficient (r) of 0.998, the development of pimvanserin tartrate was linear in the range of 0.7 to 4.2 µg/ml. The limit of detection (LOD) was found to be 7.68 ng/spot while the limit of quantification was found to be 23.28 ng/spot. The percentage label claim of pimvanserin tartrate in bulk and formulation was found to be 99 – 101 %. The percentage found in the formulation shows that no effect of excipient on drug. The conducted procedure has the benefit of being simple and quick. As a result, it can be used to examine pimvanserin tartrate in pharmaceutical formulations. Keywords: HPTLC, Pimavanserin Tartrate, Bulk and tablet formulation, Validation

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Abstract

The proposed of work to establish simple, rapid, sensitive, economical and accurate UV spectrophotometric methods for the quantificationof Pimavanserin tartrate in bulk material and in-house tablet formulation. This study is designed to validate the developed methods as per ICH guidelines. Pimavanserin tartrate an atypical anti-psychotic drug also used for the treatment of Parkinson Disease. Four simple UV Spectroscopy methods developed and validated for the estimation of Pimavanserin tartrate, by using double beam spectrophotometer (UV-2450, Shimadzu, Japan). Maximum absorbance (?max) of pimavanserin tartrate was observed at 226 nm used methanol as a solvent. The calibration curve of concentration range 5-30 ?g/ml obeyed Beer lambert law. The % recovery was found to be in the range of 98-101%. Precision values observed less than 2 in the terms of % RSD that shows precise nature of developed methods. It was concluded that statistical analysis and the result amongst all four methods, AUC method is most simple, specific, accurate and precise. All four methods can be used as routine analysis of Pimavanserin tartrate in bulk and pharmaceutical formulations. Keywords: Area under curve, Derivative-spectrophotometry, Pimavanserin tartrate, UV Spectroscopy.

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Abstract

Pirfenidone is a broad-spectrum antifibrotic medicine. In 2014, it was approved for the treatment of the idiopathic pulmonary fibrosis (IPF) by the U.S. Food and Drug Administration. Terizidone is WHO categorized group IV anti TB drug. It is an antibiotic effective against Mycobacterium tuberculosis and also M. avium for the treatment of tuberculosis, both pulmonary and extra pulmonary. The fundamental aim of this article to assemble all reported analytical methods for qualitative and quantitative analysis of Pirfenidone and Terizidone in pharmaceutical formulation as well as in biological fluids. It consist of Spectroscopy, high performance liquid chromatography, High performance thin layer chromatography. Keywords: Pirfenidone, Terizidone, Antifibrotic, Idiopathic pulmonary fibrosis, Analytical method.

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Abstract

The proposed experiments explain simple, precise, specific and accurate UV spectrophotometry methods for the estimation of Aripiprazole in bulk and pharmaceutical formulation. Aripiprazole is a recent second generation atypical anti-psychotic drug used for the treatment of schizophrenia; four simple UV spectrophotometric methods were established for estimation of Aripiprazole, using double beam UV spectrophotometer (UV-2450, Shimadzu, Japan). Aripiprazole showed maximum absorbance (? max) at 255 nm in methanolic HCl as a solvent. The calibration curve obeyed Beer-Lambert law in the concentration range of 5 -30 ?g/mL. The % recovery was found to be in the range of 98 - 100 %. Precision value less than 2 in terms of % RSD indicates precise nature of developed methods. Validation of developed methods was carried out as per ICH guidelines. It was concluded that the results and statistical analysis amongst all four methods, AUC method is most simple, accurate, precise, and specific. All four methods can be used for routine analysis of Aripiprazole in bulk and pharmaceutical formulations. Keywords: Aripiprazole, UV-Spectrophotometry, Derivatives Methods, Area Under Curve Method.

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