DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND LEVOCETIRIZINE DIHYDROCHLORIDE

  • Venkateswari P East West College of Pharmacy, Bangalore
  • Suresh Kumar G.V. East West College of Pharmacy, Bangalore
  • S. B. Puranik East West College of Pharmacy, Bangalore
  • Srinivas S East West College of Pharmacy, Bangalore
  • Ramprasad Reddy East West College of Pharmacy, Bangalore
  • Ramya G East West College of Pharmacy, Bangalore
  • Sridhar KA East West College of Pharmacy, Bangalore
  • Malla Reddy SRM University, Kattankulathur, Veeraswamy street, West Mambalam, Chennai, Tamil Nadu
Keywords: Ambroxol hydrochloride, Levocetirizine dihydrochloride, RP-HPLC, Stability studies

Abstract

A simple, precise and accurate method has been developed for simultaneous estimation of Ambroxol hydrochloride and Levocetirizine dihydrochloride. The proposed RP-HPLC method utilises Enable C18 G column (250 x 4.6mm, 5m), mobile phase consisting of Phosphate buffer pH 3.0: Methanol in the ratio of 20:80 (v/v) and UV detection at 236nm using a photodiode array detector. ambroxol hydrochloride and levocetirizine dihydrochloride were exposed to acidic, alkali, oxidative, thermal and photolytic stress conditions and the stressed samples were analysed by the proposed method. Peak homogeneity data of ambroxol hydrochloride and levocetirizine dihydrochloride in the stressed samples demonstrated the specificity of the method for their estimation in presence of degradants. The described method was linear over a range of 15 45 g/mL for ambroxol hydrochloride and 1 3 g/mL for levocetirizine dihydrochloride respectively. The method validation data showed excellent results for accuracy, precision, linearity, specificity, limit of detection, limit of quantification and robustness. The present method can be successfully used for routine quality control and stability studies.

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Author Biographies

Srinivas S, East West College of Pharmacy, Bangalore
Department of Pharmaceutical Analysis
Ramprasad Reddy, East West College of Pharmacy, Bangalore
Department of Pharmaceutical Analysis
Ramya G, East West College of Pharmacy, Bangalore
Department of Pharmaceutical Analysis
Sridhar KA, East West College of Pharmacy, Bangalore
Department of Pharmaceutical Analysis
Published
2012-07-01
How to Cite
P, V., G.V., S. K., Puranik, S., S, S., Reddy, R., G, R., KA, S., & Reddy, M. (2012). DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND LEVOCETIRIZINE DIHYDROCHLORIDE. International Journal of Advances in Pharmaceutical Analysis, 2(2), 34-40. https://doi.org/10.7439/ijapa.v2i2.17
Section
Research Articles