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

Author:

PAUL SUBRATA1,Barai Labani2,Husen Faruk3,Sarker Sabarni4,Pal Tarun Kumar5,Bai Puja6,Matin Sarker Md. Abdul7,Saima Alam Syeda8,BISWAS SHETA9

Affiliation:

1. Department of Pharmacy, University of Rajshahi, Rajshahi-6205, Bangladesh.

2. 2Department of Pharmacy, University of Asia Pacific, Dhaka-1205, Bangladesh.

3. 3Department of Applied Chemistry and Chemical Engineering, University of Rajshahi, Rajshahi-6205, Bangladesh.

4. 4Department of Pharmacy, Faculty of Life and Earth Sciences, Jagannath University, Dhaka-1100, Bangladesh.

5. 5Department of Chemistry, Rajshahi University of Engineering and Technology, Rajshahi-6204, Bangladesh.

6. 6Department of Pharmacy, Faculty of Allied Health Science, Daffodil International University, Dhaka-1207, Bangladesh.

7. 7Department of Pharmacy, Jahangirnajar University, Savar, Dhaka-1342, Bangladesh.

8. 8Department of Food Technology and Nutrition Science, Noakhali Science and Technology University, Noakhali-3814, Bangladesh.

9. 9Department of Biochemistry and Molecular Biology, Noakhali Science and Technology University, Noakhali-3814, Bangladesh.

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.

Publisher

Oriental Scientific Publishing Company

Subject

Drug Discovery,Environmental Chemistry,Biochemistry,General Chemistry

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