Application of ISO 17025 Standards in the Validation of a Spectrophotometric Method for Quality Assessment of Generic Brands of Cetirizine Tablets marketed in Nigeria.

Abstract

Background:The concern for the quality of medicines is to ensure efficacious clinical outcomes and quality health care. The World Health Organization (WHO) estimates that 10-20 % of medicines in developing country markets are sub-standard. Continuous monitoring of the quality of medicines requires both competent analysts and well-equipped drug quality control laboratories with international accreditation. The objective of the study was to evaluate the quality control parameters of the generic cetirizine dihydrochloride 10 mg tablets marketed in Abuja metropolis of Nigeria and to validate and apply a UV spectrophotometric method to the assay of the commercial tablet formulations. Method: Nine brands of cetirizine dihydrochloride tablets were randomly selected from retail pharmacy stores and quality control tests of weight variation, friability, hardness, disintegration, and dissolution parameters were conducted per United States Pharmacopoeia (USP) standards. Thickness and diameter were also evaluated by standard methods. A UV spectrophotometric method was adopted and validated according to ICH guidelines and applied for the drug assay of the tablet dosage units. Results: The thickness, diameter, hardness and disintegration tests for the drug samples ranged from 2.81-3.76 mm, 3.88-8.11 mm 1.65-7.50 KgF and 0.44-4.90 min, respectively. All the samples met the compendial specifications for the weight variation test and also for the friability and dissolution tests which ranged 0.18-0.56 % and 90.15-109.18 % at 30 min, respectively. The studies for validation of 2 the UV method demonstrated good linearity with a correlation coefficient of r = 0.9989 in the concentration range of 2.5-25 µg/mL of cetirizine dihydrochloride (CTZ) reference standard and the limit of detection (LOD) and limit of quantitation (LOQ) were 0.42 µg/mL and 1.29 µg/mL, respectively. The % RSD of the precision studies was less than the 2 % standard limit and the accuracy (recovery) ranged from 100.9-103.4 %. The percentage contents of the generic brands were determined and ranged from 99.12-103.21 % and were within the official specifications. Conclusion:The UV method was simple, sensitive and rapid and successfully applied to the assay of nine commercial brands of CTZ tablets. All the drugs met the compendial specifications on the quality parameters.