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Journal :   Research Journal of Pharmacy and Technology

Volume No. :   9

Issue No. :  1

Year :  2016

Pages :   33-43

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Development and Validation of Stability Indicating RP-HPLC Method for Combined Dosage Form of Tolperisone Hydrochloride and Diclofenac Sodium



Address:   PareshBavaliya1*, Vijay Kalkani2, RavalKashyap3
1Department of QA, Saurashtra University, Gujarat
2Asst. Prof., Department of Pharmacology, Noble Pharmacy College, Junagadh
3HOD and Asst. Prof. Department of QA, Noble Pharmacy College, Junagadh
*Corresponding Author
DOI No: 10.5958/0974-360X.2016.00007.X

ABSTRACT:
A RP-HPLC method has been developed and subsequently validated for tablet dosage form. Here we use a mobile phase consisting methanol: acetonitrile: water (80:16:4 v/v/v) Flow rate: 0.5 ml/min (pH-3 adjusted with ortho-phosphoric acid) gave better resolution of peaks in HPLC. Kromasil C18 (150mm X 4.6mm, 5µm) column was used and detection was carried out at 275nm (PDA detector). The retention time of tolperisone hydrochloride and diclofenac sodium were found at 2.93 min and 4.2 min respectively. In which Linearity for tolperisone hydrochloride and diclofenac sodium was found to be y = 5.3727x + 4514.2, R2=0.9983, and y = 9741.8x + 48158, R2=0.9995 respectively in concentration range of 0.15-1500 µg/ml and 0.05-500 µg/ml respectively. %Assay of tolperisone hydrochloride and diclofenac sodium was found to be 99.79±0.08 w/w and 99.28±0.02. Results of all other experiments for method validation (Precision, % Recovery, specificity, LOD and LOQ, Robustness) were found within the specified criteria of ICH guideline.
KEYWORDS:
Tolperisone, HCL, Diclofenac Sodium, Validation Parameter
Cite:
PareshBavaliya, Vijay Kalkani, RavalKashyap. Development and Validation of Stability Indicating RP-HPLC Method for Combined Dosage Form of Tolperisone Hydrochloride and Diclofenac Sodium. Research J. Pharm. and Tech. 9(1): Jan., 2016; Page 33-43.
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