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DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR THE ESTIMATION OF GRANISETRON HYDROCHLORIDE IN BULK AND GRANISETRON HYDROCHLORIDE MOUTH DISSOLVING FILM

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Abstract (2. Language): 
A rapid and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for estimation of Granisetron hydrochloride in bulk and pharmaceutical dosage forms. Granisetron hydrochloride was chromatographed on a reverse phase kromasil C18 column (250 x 4.6mm; 5μm) in a mobile phase consisting of 0.05 M potassium dihydrogen phosphate buffer (pH 3.0 adjusted with orthophosphoric acid) and acetonitrile in the ratio of 70:30. The mobile phase was pumped at a flow rate of 1.0 mL/min with detection at 301 nm. The retention time for Granisetron hydrochloride was 4.05min.The detector response was linear in the concentration of 1μg/mL-18μg/mL with correlation coefficient of 0.9996. The percentage recovery of granisetron hydrochloride at target concentration was found to be 94.9 %. The limit of detection and limit of quantification was found to be 0.50 μg/ml and 0.25 μg/ml respectively. Method validation parameters were found to be within the specified limits. The proposed method was found to be simple, fast, accurate, precise and reproducible and could be used for routine quality control analysis of granisetron hydrochloride in bulk and Granisetron hydrochloride mouth dissolving film.
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REFERENCES

References: 

1. L. L. Brunton, J. S. Lazo, K. L. Parker and Goodman and
Gilman’s, 11th ed., McGraw-Hill Medical Publishing
Division: New York, 407: (2005).
2. M. Aapro. The Oncologist, (9): 673-686 (2004).
3. The United States Pharmacopoeia 37, The National
Formulary 32, United States Pharmacopoeial
Convention, Inc.: Rockville, MD, 2014.
4. T. Nageswara Rao, D. Sreenivasulu, P. U. V. Satish and
T. Parvathamma. Estimation of granisetron
hydrochloride by a new RP-HPLC method, Int J Pharm
Bio Sci. July, 3(3): 412 – 419 (2012).
5. S. V. Venkata Rao, G. Ramu, D. Ravi Kumar and C.
Rambabu. A new isocratic RP-HPLC method
development for the assay of granisetron HCL in API
and dosage forms, Rasayan J. Chem. April-June, 5(2):
229-233, 2012.
6. ICH guidelines, Validation of analytical procedures:
Text and methodology Q2 (R1), 2005.

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