ISSN : 0970 - 020X, ONLINE ISSN : 2231-5039
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Abstract

Analytical Method Development and Validation for Estimation of Ranitidine in Solid Dosage Form by UV-Spectrophotometric Method

Subrata Paul1, Labani Barai2, Faruk Husen3, Sabarni Sarker4, Tarun Kumar Pal5, Puja Bal6, Md. Abdul Matin Sarker7, Syeda Saima Alam8 and Sheta Biswas9*

DOI : http://dx.doi.org/10.13005/ojc/360621


Abstract:

Ranitidine is a histamine-2 receptor blocker and it is effective against peptic ulcer, gastroesophageal reflux disease and heart burn. The main objective of this study was to develop and validate an easy, affordable and cost-effective method for the determination of ranitidine in tablet dosage form. The development and validation study was performed under the guidance of ICH and USP. Results showed that the proposed validated method has good accuracy with % RSD of 0.60. Repeatability and intermediate precision suggested good precision whereas the value of correlation coefficient 0.9999 confirmed about the linearity of the method. The system suitability data and similarity factors were also found within the permissible range. The specificity study revealed that there was no placebo and diluent effect on the absorbance. Further, stability study of analytical solutions as well as estimation of drug content from market products were also performed.

Keywords:

Accuracy; Linearity; Method Validation; Ranitidine; Uv-Spectrophotometer

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