Green spectrofluorimetric assay of dantrolene sodium via reduction method: application to content uniformity testing

Green analysis has turned out to be of a great value in all areas, including pharmaceutical analysis. Thus, it is extremely important to consider the environmental influence of each step in developing any analysis technique. The present work illustrates a validated, simple and green spectrofluorimetric method for the analysis of dantrolene sodium (DAN). The developed process is characterized by being of high sensitivity as well as being relatively inexpensive. The suggested technique based on the formation of a highly fluorescent product of DAN via its reduction by the aid of Zn/HCl system. The resulting fluorophore showed a powerful fluorescence at λ em 344 nm after excitation at λ ex 279 nm. Calibration graph revealed a great linear regression ( r = 0.9998) within concentration ranging from 0.05 to 2.0 µg ml −1 . The suggested method had very low detection and quantification limits of 0.010 and 0.031 µg ml −1 , respectively. The applied technique was effectively used in the determination of DAN in its pharmaceutical preparations. The results were compared with those from using the official United States Pharmacopeia (USP) method and they were in a good agreement. Moreover, content uniformity testing of DAN in capsules was performed adopting the investigated technique with satisfying results. The greenness of the suggested technique was confirmed by the three standard assessment tools. Therefore, the developed technique can be used in the routine quality control analysis of DAN with minimum harmful impact on nature or individuals.

Eco- Friendly Ultraviolet Spectrophotometric Determination of Allopurinol in Pharmaceutical Preparations and Environmental Wastewater Samples: Application to Content Uniformity Testing

A simple, economical and sensitive UV spectrophotometric method has been developed for the determination of allopurinol in environmental wastewater samples and, pharmaceutical preparations which shows maximum absorbance at 250 nm in distilled water. Beer’s law was obeyed in the range of 1 - 20 μg/ ml, with molar absorptive of 0.628 x104 l/mol.cm L.mol-1.cm-1 .The method was successfully applied to the determination of allopurinol in some pharmaceutical formulations (tablets) and industrial wastewater samples. The proposed method was validated by sensitivity and precision which proves suitability for the routine analysis of allopurinol in true samples.

Application of Argent Metric in the Estimation of Mesna in Tablets and Injections. Application to Content Uniformity Testing

A new, accurate, sensitive and simple indirect spectrophotometric method for the estimation of sodium 2-mercaptoethanesulfonate (mesna) has been developed. This procedure base on the reaction of mesna with excess of silver nitrate and a known amount of methyl orange and the increase in absorbance at 520 nm, caused by a decrease in pH due to release of nitric acid, is measured and related to drug concentration .The absorbance results increased with increasing concentration of mesna . Beer’ s law is obeyed and linear at the concentration range of 2-28µg/ml. Apparent molar absorbance, Sand ell’s sensitivity values were 7.16×103 Lmol-1cm-1. And 22.93 ng.cm-2 respectively, The present method is considered to be simple because it does not need either heating or hydrolysis or solvent extraction steps. The ingredients often formulated with Metoclopramide hydrochloride have been shown not to interfere, and the proposed method is suitable for the routine determination of mesna. The (RSD) of this method was less than 2 and average recovery (accuracy) is 100 ± 0.75. The method applied successfully for estimation of mesna in (tablets and injections pharmaceutical formulations).and Application to Content Uniformity Testing

Validated HPLC Method for Assay and Content Uniformity Testing of Roflumilast in Blend and Tablets

Roflumilast is a selective enzyme inhibitor of phosphodiesterase-4. This drug is recommended for treatment of patients suffering from chronic-obstructive-pulmonary-disease with chronic-bronchitis. Roflumilast is not official in pharmacopoeia and the reported methods are having high chromatographic run times. A short run time HPLC method was developed for assay and content uniformity testing to determine the roflumilast in blend and tablets. The mobile phase consists of 10 mM sodium dihydrogen phosphate monohydrate buffer and acetonitrile in the ratio of 45:55 v/v. The HPLC method was developed using accucore-C18 150 × 4.6 mm, 4 μm column with a flow rate of 1.0 mL min-1, 215 nm wavelength and 10 μL injection volume with run time of 5 min. The method linearity was proved between 5.02-40.17 μg mL-1 and obtained correlation-coefficient value is 1.0000. The mean recovery of roflumilast was 100.6%. The stability indicating nature was established and performed the validation by considering ICH Q2 (R1) recommendations.