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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