Lata P. Kothapalli, Madhav S. Panchaware, Rabindra K. Nanda, Asha B.Thomas
Lata P. Kothapalli*, Madhav S. Panchaware, Rabindra K. Nanda, Asha B.Thomas
Department of Pharmaceutical Chemistry, Padm. Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune 18, Maharashtra, India
Volume - 5,
Issue - 8,
Year - 2012
A stability indicating high performance thin layer chromatography (HPTLC) method was developed and validated for determination of Lisinopril Anhydrate (Lisino) and S-Amlodipine Besylate (S-Amlo) in combined dosage form used for treatment hypertension. Pre-coated silica gel HPTLC plates were used as stationary phase and n-butanol: methanol: 25% ammonia solution (4:4:2 v/v/v) as the mobile phase to resolve the two drugs with Rf values 0.28 and 0.80 for Lisino and S-Amlo respectively. A TLC scanner set at 218 nm was used for direct evaluation of the chromatograms in the reflectance/absorbance mode. The correlation coefficients of calibration curves were found to be 0.991 and 0.995 in the concentration range of 2000-12000 ng/band and 1000-6000 ng/band for Lisino and S-Amlo respectively. Method was validated according to ICH guidelines. The method had an accuracy of 99.70-99.91% for Lisino and 99.66-99.92% for S-Amlo. The method determined the two drugs simultaneously from dosage forms without any interference of the tablet excipients. Lisino and S-Amlo were also subjected to acid, base, oxidation, heat and photo-degradation studies. The degradation products obtained were well resolved from the pure drugs. As the method could effectively separate the drugs from its degradation products, it can be used as a stability-indicating assay.
Cite this article:
Lata P. Kothapalli, Madhav S. Panchaware, Rabindra K. Nanda, Asha B.Thomas. Stability-Indicating HPTLC Method for Simultaneous Determination of Lisinopril Anhydrate and S-Amlodipine Besylate in Pharmaceutical Dosage Form. Asian J. Research Chem. 5(8): August, 2012; Page 1061-1066.