STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR COMBINED DOSAGE FORM OF TOLPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM

  • Paresh Bavaliya Saurashtra University, Gujarat
  • Vijay Kalkani Noble Pharmacy College, Junagadh
  • Raval Kashyap Noble Pharmacy College, Junagadh
DOI: https://doi.org/10.53555/bs.v2i1.1580
Keywords: Tolperisone, HCL,, Diclofenac Sodium, Validation Parameter

Abstract

A simple HPTLC method has been developed and subsequently validated for tablet
dosage form. The method employed TLC aluminum plates precoated with silica gel
60F254 as the stationary phase. The solvent system consist of Methanol: Toluene:
Ethyl Acetate (2.5:7:0.5 v/v/v) and saturation time was 25 min.This system was found
to give compact spots for diclofenac sodium (Rf =0.7±) and tolperisone hydrochloride
(Rf 0.5).Analysis of tolperisone hydrochloride, diclofenac sodium was carried out at
275nm. Linearity of diclofenac sodium and tolperisone hydrochloride was found to be
y = 5.3727x + 4514.2, R2=0.998, y = 9.376x + 2635.6, R2=0.995 respectively in
concentration range of 300-1500 µg/bandand 100-300 µg/band. %Assay of
tolperisone hydrochloride and diclofenac sodium was found to be 99.16%w/v and
99.60 %w/v.Results of all other experiments for method validation were found within
the specified criteria of ICH guideline.

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Author Biographies

Paresh Bavaliya, Saurashtra University, Gujarat

Department of QA, Saurashtra University, Gujarat

Vijay Kalkani, Noble Pharmacy College, Junagadh

Asst. Proff

Department of Pharmacology, Noble Pharmacy College, Junagadh

Raval Kashyap, Noble Pharmacy College, Junagadh

Asst. Proff.& Head,

Department of QA, Noble Pharmacy College, Junagadh

Published
2016-01-31
How to Cite
Bavaliya, P., Kalkani, V., & Kashyap, R. (2016). STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR COMBINED DOSAGE FORM OF TOLPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM. IJRDO - JOURNAL OF BIOLOGICAL SCIENCE, 2(1), 66-88. https://doi.org/10.53555/bs.v2i1.1580
Issue
Vol. 2 No. 1 (2016): IJRDO - Journal of Biological Science
Section
Articles

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