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Research Journal of Pharmacy and Technology
Year : 2016, Volume : 9, Issue : 1
First page : ( 33) Last page : ( 43)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2016.00007.X

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

Bavaliya Paresh1,*, Kalkani Vijay2, Kashyap Raval3

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 E-mail:

Online published on 9 March, 2016.

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.

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Keywords

Tolperisone, HCL, Diclofenac Sodium, Validation Parameter.

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