Journal of Pharmaceutical Research

S. P. Mahaparale ¹, I. D. Gonjari ², K. N. Jayaveera ³

Affiliations
1 Padm. Dr. D. Y. Patil College of Pharmacy, Sector No. 29, Pradhikaran, Near ZSI Building, Akurdi, Pune - 411 044, Maharashtra, IN
2 Government College of Pharmacy, Vidyanagar, Karad - 415 124, Maharashtra, IN
3 Jawaharlal Nehru Technological University, Anantapur - 515 002, Andhra Pradesh, IN

Abstract

The present paper describes simple, rapid, reproducible, accurate and precise stability indicating HPLC method developed for quantitative simultaneous estimation of metoprolol succinate and olmesartan medoxomil in bulk and combined pharmaceutical dosage form. A chromatographic separation of both drugs was achieved with Chromasil 250 × 4.6 mm, i.d 5 μm C-18 column using methanol:0.05% v/v Ophosphoric acid in water (50:50 v/v) at the flow rate of 1ml/min. The measurements were made at 228.0 nm as detector wavelength. The described method showed excellent linearity over a range of 5-80 μg/ml for metoprolol succinate and 5-70 μg/ml for olmesartan medoxomil. The coefficient of correlation for metoprolol succinate and olmesartan medoxomil was found to be 0.9990 and 0.9993 respectively. The retention time for metoprolol succinate and olmesartan medoxomil was found to be 3.485 min and 7.085 min, respectively. The tailing factor for metoprolol succinate and olmesartan medoxomil was found to be 1.02 and 1.13 respectively. Both drugs and their combination drug product were found to be stable in neutral, thermal, oxidative and photolytic stress conditions but mild degradation was observed in acidic and alkaline conditions.

Keywords

Metoprolol Succinate, Olmesartan Medoxomil, HPLC Method Validation, Stability-Indicating Method, ICH Guidelines.

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G. Parthasarathy ¹, K. Bhaskar Reddy ², K. N. Jayaveera ³

Affiliations
1 Department of Pharmaceutics, R.R College of Pharmacy, Chikkabanavara, Bangalore-560 090, KA, IN
2 Sri Venkateswara College of Pharmacy, Chittoor- 517 127, AP, IN
3 Department of Chemistry, JNTUA, Anantapur- 515 001, AP, IN

Abstract

The delivery of drug through buccal mucosa provides potential advantages like prevention of enzymatic degradation in gastro intestinal tract and bypassing hepatic first-pass metabolism. However the significant aspect in transbuccal drug delivery is the very restrictive passage of drug through the buccal mucosa. In our earlier work we confirmed the ability of Carbamazepine (CBZ) to permeate through the porcine buccal mucosa. Our earlier study proved that CBZ crosses the membrane by passive diffusion. But the measured Flux (J_s) and permeation coefficient (K_p) of CBZ was s p insufficient to achieve plasma therapeutic concentration. In this study an approach was made to improve permeability of CBZ using some bile salts as chemical permeation enhancers like sodium taurocholate (STC) and sodium taurodeoxycholate (STDC) which are capable to lessening the barrier property of the mucosal tissue. These patches were subjected to ex vivo permeation studies. The six buccal patches of CBZ selected from our earlier reported formulations were subjected to this permeability improvement study. These patches were either based on HPMC K15M or Carbopol 934p or Chitosan in combination of PVA or PVP K30 or Sodium alginate. The significant change in J_s and K_p of formulations in presence and absence of chemical permeation enhancers STC or STDC (in two different p concentrations 0.1% and 0.5 % w/w) was evaluated by ex vivo permeation studies through porcine buccal mucosa under modified Franz diffusion cell. The calculated value of Flux (J_s) and Permeation coefficient (K_p) confirmed that s there was a significant increase in permeated amount of CBZ after the inclusion of permeation enhancers. The compatibility of bile salts with buccal mucosa was examined by histological studies and kinetic studies.

Keywords

Carbamazepine, Buccal Patch, Permeation Enhancer, Bile Salt.

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