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VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DROTAVERIN.HCL & ACECLOFENAC IN BULK AND FORMULATION

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ABOUT AUTHORS
A. PADMA1*, D. GIRIJA2, A. THIRUPATHIREDDY3, B. VENKATESWARAREDDY4
1Department of Pharmaceutical Analysis, Sankar Reddy Institute of Pharmaceutical sciences, Salakalveedu(v), Bestavaripeta(M), Prakasam (Dist) Andhra Pradesh, India
2Department of Pharmaceutical Analysis, Sankar Reddy Institute of Pharmaceutical sciences, Salakalveedu(v), Bestavaripeta(M), Prakasam (Dist) Andhra Pradesh, India
3Department of Pharmaceutics, Sankar Reddy Institute of Pharmaceutical sciences, Salakalveedu(v), Bestavaripeta(M),Prakasam(Dist) Andhra Pradesh, India
4Department of Pharmaceutics, Sankar Reddy Institute of Pharmaceutical sciences, Salakalveedu(v), Bestavaripeta(M), Prakasam(Dist) Andhra Pradesh, India

ABSTRACT
The present research work deals with the development  and validation of  stability indicating RP-HPLC method for the simultaneous estimation of Aceclofenac and Drotaverin.HCl in bulk and formulation. Chromatographic separation was achieved on ODS HG-5 RP   C18(250 X 4.6 mm, 5 µm) using the mobile phase consisting of Acetonitrile and1% triethylamine (TEA) in the ratio of 90:10 pH  2.16 adjusted with Ortho phosphoric acid. The mobile phase was pumped at a flow rate of 1.0 mL/min and UV detection was observed  at 224 nm. The retention time was found to be 3.57 min for Aceclofenac and 6.15 min for Drotaverin.HCl. The linearity concentrations are obtained from in the range of 30-70 µg/ml for Aceclofenac and 24-56 µg/ml for Drotaverin.HCl respectively with correlation coefficient was 0.999 and 0.998. The proposed method was found to be simple, accurate, precise and reproducible and developed method can be suggest to routine quality control analysis for simultaneous estimation of Aceclofenac and Drotaverin.HCl in pharmaceutical dosage forms.

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Data Integrity Workshop - 2019
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INTERNATIONAL PHARMACEUTICAL DATA INTEGRITY CONFERENCE - 2019

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Compliance Trainings invites you to our International Pharmaceutical Data Integrity Workshop - 2019, that includes Overview, Discussion panels, Interactive Training sessions, Exercises and Keynote presentations. Facilitated by ex-FDA Official - Mr. Brian G. Nadel and other data integrity experts. You will have the opportunity to deepen your understanding of effective practices and apply your acquired data integrity knowledge to real-life scenarios.

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