Stability Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Drotaverine Hydrochloride and Aceclofenac in Bulk and Tablet Dosage Form

Author(s): Rajitha Galla*, Shyamala Uddala, Geetha Susmita Adepu and Nithya Somanjeri

Abstract: Objective: To develop a simple, reproducible and economical reverse phase high performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of drotaverine hydrochloride and aceclofenac in bulk and tablet dosage form and to validate it as per international conference on harmonization (ICH) guidelines. Methods: The quantification was carried out on a Hypersil ODS 250 mm×4.6 mm, 5μ column in isocratic elution mode with mobile phase ortho-phosphoric acid buffer (pH 2.8) and acetonitrile in the ratio 20:80 v/v. The mobile phase was pumped at a flow rate of 1.0 ml/min. The detection was carried out at 210 nm using photo diode array detector. Results: The retention times of drotaverine hydrochloride and aceclofenac were found to be 3.152 and 2.921 minutes respectively. The developed method was linear for drotaverine hydrochloride and aceclofenac over the concentration range of 25- 150 % and 20-120 % with correlation coefficient (r2) values 0.9998 and 0.9996 respectively. The LOD and LOQ for drotaverine hydrochloride and aceclofenac were 0.11, 0.06 and 0.34, 0.18 μg/ml correspondingly. The mean percent recoveries of drotaverine hydrochloride and aceclofenac were 100.04% and 100.3% and were within the limits (98%-102%). Conclusion: The validation of the method revealed that the proposed method was found to be selective, linear, accurate, precise and robust and hence it can be used for routine analysis.

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