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Abstract

A COMPARISON OF THE TECHNICAL QUALITY OF NEPALESE AND INDIAN RANITIDINE HYDROCHLORIDE TABLETS AVAILABLE IN POKHARA

Parbati Thapa*, Mukti Nath Barakoti, Affjal Khan, Bijay Kafle, Prakash Mahara, Raj Kumar Thapa

ABSTRACT

Ranitidine is available in several brands in the market which makes it difficult to select the safe and effective one for peptic ulcer therapy. Study aimed to establish pharmaceutical equivalence among the different brands of Ranitidine HCl tablets available in Pokhara. Ten different brands of Ranitidine HCl film coated tablets (150 mg) produced and marketed by Nepalese and Indian pharma companies available in Pokhara were included in study. Five quality control parameters: weight and weight variation test, hardness test, disintegration test, dissolution test and assay along with price variation study were carried out. All the brands met the compendial requirement for weight and weight variation test specified by IP (Indian Pharmacopoeia). Hardness value requirement was complied by all brands except IR3. Disintegration time for all brands was within 15 minutes complying the IP recommendation. All brands showed more than 80 % drug release within 45 minutes. The drug content assays for all brands fell within the IP specification except for IR4 which was found to exceed the limit. There was a large range of price variation between all the brands. Nepalese brands showed higher price to patient value than Indian brands. The present findings suggest that almost all the brands of Ranitidine HCl that are available in Pokhara valley meet the IP specification for quality control analysis. However, significant differences in quality control parameters are observed between the different brands.

Keywords: Ranitidine HCl, Quality control, Pharmaceutical equivalent.


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