World Journal of
Pharmaceutical and Life Sciences

PHYSICOCHEMICAL QUALITY ASSESSMENT OF VARIOUS BRANDS OF LEVOCETIRIZINE DIHYDROCHLORIDE FILM-COATED TABLETS, COMMERCIALLY AVAILABLE IN SALALAH, SULTANATE OF OMAN

Ayushman Dash and *Hare Krushna Dash

ABSTRACT

Generic drugs are generally less expensive than innovator drugs, which can make them more accessible to a
broader population. How ever, generic drugs, must meet the same quality and safety standards in comparison with
innovator drugs. Quality control and regulatory oversight become crucial to ensure that these generics meet the
required standards. Three brands of Levocetirizine dihydrochloride were purchased from different local retail
stores. We assessed the quality and equivalency of 3 different Generic brands of Levocetirizine dihydrochloride
film-coated tablets against Innovator brand “Xyzal” serving as the reference. All the experiments are carried out by
using validated HPLC methods in Oman Pharmaceutical products Co. L.L.C., Sultanate of Oman. The tablets were
evaluated for weight variation, hardness, water content by KF, disintegration time, drug content, and
pharmaceutical equivalence was determined from the dissolution profile which gives acceptable difference (f1) and
similarity (f2) factor values for all the brands compared with the Innovator brand “Xyzal”. The physicochemical
parameter results for all three brands met the acceptable limits. All the 3 brands also met the USP criteria for assay
of not less than 90.0% and not more than 110.0% of the labeled amount of levocetirizine dihydrochloride. All the 3
brands showed evidence of dissolving within 15 minutes. The values observed are within the recommended range
of 80 (Q) within 30 minutes for oral solid dosage forms intended for immediate release. According to the f1 and f2
results, all 3 brands were comparable to Innovator “Xyzal”, and demonstrated similar dissolution profiles and
could potentially be used interchangeably with “Xyzal”.

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