Quality Control of Hydrochlorothiazide Pharmaceuticals

ABSTRACT

Background One of the organisational strategies to ensure the use of relevant good practises for each stage in the life cycle of pharmaceutical products is the market surveillance program, which aims to demonstrate product specification adherence. It uses analytical pharmacopoeial and literature-based approaches primarily to carry out quality control on the chosen pharmaceutical items. Aim Development of a program for analytical control of different medicinal products containing 25 mg hydrochlorothiazide. Materials and Methods European Pharmacopoeia and USP HPLC methods for assay and related substances were applied in prescription medicines. Results The system suitability tests were evaluated for each method, and the results of each generated group of products were compared. The quantitative content values deviation and the quantitative limitations for each impurity were determined. The deviations are in the range 0.76%-4.01%. Calculated RSD values are below 2%. The results obtained by both methods are within the acceptable limits of 95%-105%. In the European Pharmacopoeia method, the limits of three impurities were determined and seven more were found and marked as unknown. The USP method allows identification of only one impurity. Conclusion For the market surveillance program for pharmaceuticals containing hydrochlorothiazide, an analytical control program has been developed. The program combines multiple pharmacopoeial HPLC methods and compares the outcomes with an initial assessment of each method’s applicability for all pharmaceuticals containing hydrochlorothiazide.

KEYWORDS

• Market Surveillance Program
• HPLC
• Hydrochlorothiazide
• System suitability test

Showing references and in-text citations exactly as published.

• DOI10.5530/ijper.58.3s.101Copy

RELATED ARTICLES

Matched on section and article type within this issue of IJPER.

• Article · VOLUME 58, ISSUE 3SLow Dose Lipopolysaccharide-Induced Depressive-Like Phenotype is Mediated by Proinflammatory Cytokines in Mice and Role of KetamineShuvranshu Praharaj, Vandurayanpet Kaliyamoorthy Kalaichelvan, Vedigounder Murugan, Velappan Venkatachalam, Ishtiyaque Ahmad · pp. s777–s786Original ArticleSame type: Article
• Article · VOLUME 58, ISSUE 3SInterstitial Lung Diseases Classification in the Context of Pharmaceutical Education and Research: A Two-Level Deep Learning ApproachVanita Dnyandev Jadhav, Lalit Vasantrao Patil · pp. s787–s795Original ArticleSame type: Article
• Article · VOLUME 58, ISSUE 3SComputational Study and Evaluation of Lidocaine and Nitroglycerin Ointment for External Hemorrhoid TreatmentArwa Alshargabi, Wafa Mohammed Al-Madhagi, Abdulkarim Kassem Alzomor · pp. s796–s804Original ArticleSame type: Article
• Article · VOLUME 58, ISSUE 3SSmart Manipulated UV Spectroscopic Methods for Resolving the Overlapped Spectra for Quality Control of Two Analgesic Binary Combination FormulationsMahesh Attimarad, Bandar Aldhubiab, Sreeharsha Nagaraja, Shinu Pottathil · pp. s796–s804Original ArticleSame type: Article