quality control

The main purpose of this review is to highlight the importance of colorimetric approaches to drug analysis both in dosage forms as well as biological samples. Colorimetric methods using colorimetric reagents are highly sensitive, specific and an easy way of determining various analytes in a variety of matrices within a short time. The colorimetric procedures discussed are statistically validated and reported in various quality control laboratories. Hence in the present review significance of colorimetric procedures, various reagents used along with principles and applications are mentioned. Key words: Colorimetric approaches, sensitive, matrices, quality control, applications.

Ranitidine hydrochloride tablet is used as a drug of choice for peptic ulcer therapy. It is   available in several brands in the Sudanese pharmaceutical market. The aim of this study was to evaluate the quality, safety and efficacy of the different brands and to assure the interchangeability among different brands and the originator (Zantac®).Four brands available in the market were assessed “evaluated” using pharmacopoeial parameters for quality such as weight variation test, hardness test, friability test, dissolution test and assay along with the similaritydissimilarity factors were evaluated. The results obtained in this study showed that the different brands satisfied pharmacopoeial parameters, although not all of them were pharmaceutically equivalent or interchangeable with the originator. Key words: Ranitidine, Sudanese drug market, quality control, interchangeable.  

A stability indicating RP-HPLC method was developed for the simultaneous determination of Spironolactone (SRL) and Hydroflumethiazide (HFM) in pharmaceutical dosage form. Inertsil ODS - C18 (250 mm x 4.6 mm, 5 µm) column and mobile phase of methanol: acetonitrile : phosphate buffer in the ratio of 55:40:05 v/v at a flow rate of 1.0 mL/min was used for separation of the components. The components were detected at a wavelength of 221nm using UV detector. The Spironolactone and Hydroflumethiazide were separated at retention time 4.67 and 6.74 min respectively. The developed method was validated in terms of precision, accuracy, linearity, specificity, limit of detection, limit of quantitation. The range of linearity was found to be 5-30 µg/mL for Hydroflumethiazide and 5-30 µg/mL for Spironolactone. The proposed method was applied to study the stability of the drugs under different degradation conditions such as acid, alkali, peroxide, thermal and photo light. The developed method was found to be simple, sensitive and rapid and hence, It can be adopted in any laboratory for quality control analysis.

The current concept of good manufacturing practices (GMP) emphasizes that the quality of pharmaceutical products should be constructed during the overall process cycle. Quality control department plays an important role in the quality-by- design (QbD) concept since it demands the acquisition of in-process reliable analytical data. Quality control department should demonstrate the quality of their results and their fitness for purpose by giving a measure of the confidence that can be placed on the results. One useful measure of this is measurement uncertainty. The present article covers the sources, reasons and evaluation of measurement uncertainty.