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Research Journal of Science and Technology
Year : 2020, Volume : 12, Issue : 1
First page : ( 23) Last page : ( 35)
Print ISSN : 0975-4393. Online ISSN : 2349-2988.
Article DOI : 10.5958/2349-2988.2020.00003.0

Analytical Method Development and Validation of Paliperidone: A Review

Tambe Rupali1,*, Mankar Someshwar2,**, Dighe Santosh2,***

1Research Scholar, Pravara Rural College of Pharmacy, Pravaranagar, Tal, Rahata, District-Ahmednagar, Maharashtra, India

2Assistant Professor, Pravara Rural College of Pharmacy, Pravaranagar, Tal, Rahata, District-Ahmednagar, Maharashtra, India

*Corresponding Author E-mail: rupalitambe897@gmail.com

**sdmankar655@gmail.com

***sbdigheprcop@gmail.com

Abstract

A Simple, precise, Sensitive, rapid, specific and accurate analytical HPLC method have been developed for the estimation of paliperidone in Bulk & Pharmaceutical dosage forms. Paliperidone is atypical antipsychotic. The methods can be used for routine analysis for the estimation of paliperidone in formulations. Hence, this technique would be applied used for quantification of paliperidone in bulk and solid dosage formulation. The projected method was validated for various ICH parameters like linearity, limit of detection, accuracy, precision, ruggedness, robustness and system suitability. The RP-HPLC method was developed for determination of drug in pharmaceutical formulation. The presented study is simple, since samples are directly used without any preliminary chemical dramatization or purification steps. Generally a RP-HPLC assay utilize Symmetry C18 or equivalent with mobile phase composition of pH 7 buffer: acetonitrile [40: 60] was used, and flow rate was 0.8 ml min-1 with UV detection at 285 nm.

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Keywords

Paliperidone, antipsychotic, RP-HPLC, ICH parameters, Validation, pH 7 bufferacetonitrile.

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