Volume No. :   12

Issue No. :  1

Year :  2020

ISSN Print :  0975-4393

ISSN Online :  2349-2988


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Analytical Method Development and Validation of Paliperidone: A Review



Address:   Rupali Tambe*1, Someshwar Mankar2, Santosh Dighe2
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
DOI No: 10.5958/2349-2988.2020.00003.0

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.
KEYWORDS:
Paliperidone, antipsychotic, RP-HPLC, ICH parameters, Validation, pH 7 buffer: acetonitrile.
Cite:
Rupali Tambe, Someshwar Mankar, Santosh Dighe. Analytical Method Development and Validation of Paliperidone: A Review. Research J. Science and Tech. 2020; 12(1):23-35.
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