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Dissolution Method Development and Validation for Combination Dosage Form of Telmisartan and Nebivolol hydrochloride Tablets using UV Spectrophotometric Method


Affiliations
1 M M College of Pharmacy, Markandeshwar (Deemed to be University), Mullana, Ambala-133207, Haryana, India
2 M M University, Solan, Himachal Pradesh, India
3 Reginal Drugs Testing Laboratory, Ballari, Karnataka, India
     

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The combination tablets dosage form of Telmisartan and Nebivolol hydrochloride dissolution method was developed by UV spectrophotometer and validated was according to the ICH guidelines. The any official method of this combination drugs was not available. In this proposed method two commercial brands of drug was used. The simultaneous estimation of Telmisartan and Nebivolol hydrochloride was performed in this proposed method which includes to solving of simultaneous equation. The wavelength of Telmisartan 296nm and 281nm of Nebivolol hydrochloride was used in this simultaneous equation. The dissolution mediums such as 0.1N HCl, phosphate buffer, SFG (without enzyme) at various ph was used in this method. The selected proposed dissolution method was SFG dissolution media (without enzyme) 900 ml, speed 75 rpm, USP type II apparatus and temperature at 37 ± 0.5°C and drug release than 85% within 45mints. The optimized proposed method easy to handle and commercially used for the routine quality control checking of Telmisartan and Nebivolol hydrochloride pharmaceutical combine tablets dosage form.

Keywords

Telmisartan, Nebivolol Hydrochloride, Simultaneous Equation, Dissolution, Validation, ICH Guidelines.
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  • Dissolution Method Development and Validation for Combination Dosage Form of Telmisartan and Nebivolol hydrochloride Tablets using UV Spectrophotometric Method

Abstract Views: 278  |  PDF Views: 0

Authors

Chinmoy Kumar
M M College of Pharmacy, Markandeshwar (Deemed to be University), Mullana, Ambala-133207, Haryana, India
Manish Kumar
M M College of Pharmacy, Markandeshwar (Deemed to be University), Mullana, Ambala-133207, Haryana, India
Vipin Saini
M M University, Solan, Himachal Pradesh, India
Shailendra Bhatt
M M College of Pharmacy, Markandeshwar (Deemed to be University), Mullana, Ambala-133207, Haryana, India
A. Pandurangan
M M College of Pharmacy, Markandeshwar (Deemed to be University), Mullana, Ambala-133207, Haryana, India
Anuj Malik
M M College of Pharmacy, Markandeshwar (Deemed to be University), Mullana, Ambala-133207, Haryana, India
Preeti Pal
M M College of Pharmacy, Markandeshwar (Deemed to be University), Mullana, Ambala-133207, Haryana, India
Laxmi Narayan Shetty
Reginal Drugs Testing Laboratory, Ballari, Karnataka, India

Abstract


The combination tablets dosage form of Telmisartan and Nebivolol hydrochloride dissolution method was developed by UV spectrophotometer and validated was according to the ICH guidelines. The any official method of this combination drugs was not available. In this proposed method two commercial brands of drug was used. The simultaneous estimation of Telmisartan and Nebivolol hydrochloride was performed in this proposed method which includes to solving of simultaneous equation. The wavelength of Telmisartan 296nm and 281nm of Nebivolol hydrochloride was used in this simultaneous equation. The dissolution mediums such as 0.1N HCl, phosphate buffer, SFG (without enzyme) at various ph was used in this method. The selected proposed dissolution method was SFG dissolution media (without enzyme) 900 ml, speed 75 rpm, USP type II apparatus and temperature at 37 ± 0.5°C and drug release than 85% within 45mints. The optimized proposed method easy to handle and commercially used for the routine quality control checking of Telmisartan and Nebivolol hydrochloride pharmaceutical combine tablets dosage form.

Keywords


Telmisartan, Nebivolol Hydrochloride, Simultaneous Equation, Dissolution, Validation, ICH Guidelines.

References