Nitrosamine impurities have been detected in various pharmaceutical products in recent days. Various sartans, ranitidine, nizatidine and metformin have been recalled from the markets due to the high limit of nitrosamine impurities. When assessing the danger of human cancer, pharmaceutical products ability to regulate potentially mutagenic and carcinogenic contaminants is crucial. The risk of their mutagenic and carcinogenic potential has increased with the recent finding of nitrosamine impurities in various commercially available medications. Nitrosamine is the substance deemed to be a potential human carcinogen by the International Agency for Research on Cancer (IARC). Impurities in nitrosamines have been shown to be mutagenic and carcinogenic; even very low exposure levels to these impurities can cause cancer. These impurities may be created by a reagent, catalyst, solvent, or raw materials employed in the manufacturing process and end up in drug substances or drug products. Angiotensin II receptor blocker (ARB) medications with nitrosamine impurities have caused widespread health problems. Risk management of nitrosamine impurity is necessary to control the level of this impurity in drug substance, drug product and APIs. By using risk management tools like fishbone diagram which is used to identify and organize the possible sources of nitrosamines in medicines. For detection of nitrosamine impurity different countries develops their own analytical methods.

Non-steroidal anti-inflammatory drugs are the common and novel category of drugs which are widely used for the treatment of pain, inflammation and fever. NSAIDs inhibit the synthesis prostaglandins by the action on the cyclooxygenase enzymes. This review revealed the analytical method reported in literature for the determination of zaltoprofen, loxoprofen, ketoprofen, and flurbiprofen in pharmaceutical formulations in alone and combinations with other drugs. The comparison of twenty one analytical methods, including HPLC, UV-Spectrophotometry, and bioanalytical procedures, is most effectively illustrated in this comprehensive overview. To produce trustworthy data for regulatory filings, analytical development needs to be tested. A revolution in human health was brought about by the development of pharmaceuticals.

Demand for ODT is increasing day by day particularly in pediatric, geriatric and patients with some sort of disabilities in swallowing. ODTs are those tablets which gets rapidly dissolved in saliva. They do not need water for administration. Oral dispersible tablets are also known as fast melting tablets. The current article reviews the introduction, ideal characteristics, advantages and disadvantages, limitations, challenges in formulating ODTs, formulations of ODTs, technologies used in ODTs, selection of superdisintegrants and evaluation methods.

Objective: There are several methods for analyzing the same, however, they are time-consuming and costly. We created a new spectrophotometric method for determining Dolutegravir (DLT) in tablet dosage forms that is simple, accurate, and precise. We developed and validated a simple, accurate, and precise colorimetric method for the quantitative analysis of Dolutegravir in bulk and dosage form by ICH recommendations in this study. Methodology: There are several methods for analyzing the same, however, they are time-consuming and costly. We created a new spectrophotometric method for determining Dolutegravir (DLT) in tablet dosage forms that is simple, accurate, and precise. In methanol, the initial stock solution of Dolutegravir was prepared. The method is based on the formation of a blue color chromogen complex from Dolutegravir oxidation-reduction with Ferric chloride in the presence of potassium ferricyanide. Result: The color complex was measured at 710nm. Beers law was observedin the concentration range of 3.5-6.5μg/ml witha coefficient of correlation (R2) was 0.998. The system suitability criteria were found to be within the limits. The LOD and LOQ were found to be 0.91 and 2.47, indicating that the method is sensitive. Conclusion: The relative standard deviation (RSD) and percent recovery values were found to be satisfactory, indicating that the proposed method is suitable, accurate, and precise and that it can be used in routine analysis of Dolutegravir in tablet dosage forms, with relatively low-cost solvents.

A simple, precise, accurate stability-indicating method was developed and validated for Acebrophylline in bulk and tablet dosage form. The chromatographic separation was achieved by using Methanol: Acetonitrile: Acetone: Formic acid (4:4:2:0.1 v/v/v/v) as mobile phase and UV detection at 272nm. The retention factor for Acebrophylline was found to be 0.74±0.10. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation, and robustness as per ICH guidelines. Results were found to be linear in the concentration range of 400-2400ng band -1 with a correlation coefficient of 0.9921. The % assay was found to be 102.4±5. The drug was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis, and thermal degradation. The developed method can be used for the quantification of drug in the dosage form, bulk drug as well as for routine analysis in quality control laboratories.

A simple and robust reversed-phase high pressure liquid chromatographic method was developed and validated for the quantification of Mometasone and Formoterol in bulk and fixed dosage forms. The column utilized for study was Inertsil C18, ODS was chosen for good peak shape. Ambient temperature was found to be suitable for the nature of drug solution. The mobile phase was streamlined with a ratio of 35:65 Methanol: Water was optimized for symmetrical peaks and good resolution. The flow rate was streamlined at 1.0 ml/min because of good peak area, satisfactory retention time and good resolution. Common λ-max was found to be at 278 nm and Injection volume was 20 µl which gave a good peak area. The percentage recovery was found to be 98.0-101.50 was linear and precise over the same range. Both system and method precision was found to be accurate and well within the acceptable limits. Detection limit was found to be 0.25 Mometasone and 0.34 for Formoterol. The analytical method was found linearity over the range of 20-80 ppm of the target concentration for both the drugs. The LOD and LOQ values for Mometasone, was observed to be 0.25 and 0.77 and for Formoterol was in the range of 0.34 and 1.05 consecutively. The analytical method passed both intermediate precision and robustness tests. On both cases, relative standard deviation was well satisfactory. The validation experiments met ICH standards. It inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.

A simple, sensitive, accurate, precise and economical visible Spectrophotometric method was developed and validated for the estimation of Atorvastatin in Bulk form. The method is based on the reaction of Atorvastatin with MBTH Reagent [3-Methyl-2-Benzothiazolinone Hydrazone] in the presence of ferric chloride giving greenish blue colour chromogen which shows maximum absorbance at 566nm against reagent blank. The Chromogen obeyed Beer’s law in the concentration range of 5-25 µg/ml for Atorvastatin. The results of the analysis have been validated statistically and recovery studies confirmed the accuracy of the proposed method.

Andrographis paniculata is one of the important ingredient used in various Siddha formulations. The present study is mainly aimed to compare various marketed nilavembukudineer churna on the basis of andrographolide content. HPTLC method was used for this determination using marker compound andrographolide. The HPTLC method was performed using HPTLC aluminium sheets precoated with silica gel 60 GF254 as stationary phase and ethyl acetate: n-hexane (8.5:1.5 v/v) as the mobile phase. The developed chromatogram was scanned at 233nm using Camag scanner III. The reference standard andrographolide Rf value was found to be 0.55.Fromthe five market formulations screened, the andrographolide content in methanolic and aqueous extracts showed the discrepancy in content amount representing by order MFM-1 MFA-1 MFM-2 MFA-2 -3.The other market formulation extracts both methanol and aqueous extracts does not confirms the presence of andrographolide.

A new, simple, rapid, selective, precise and accurate isocratic reverse-phase high-performance liquid Chromatography assay method has been developed to estimate Linezolid in tablet formulations. The separation was achieved using column Inert sustain C18 (250×4.6mm, 5µ) in the mobile phase consisting of methanol: 1% Acetic acid (50:50 v/v). The flow rate was 0.80mL/min-1, and the separated Linezolid was detected using a UV detector at 249nm. Column temperature 45°C and sample temperature ambient and injection volume 20µL. The retention time of Linezolid was noted to be 7.3min. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.

Background: In this work, a novel, simple and accurate reverse phase high-performance liquid chromatographic method with UV detection is presented for the simultaneous estimation of Benidipineand Telmisartan in API and marketed formulations. Objective: To develop and validate this method in accordance to regulatory guidelines i.e. ICH Q2B-R1 for analytical parameters. Methods: In RP-HPLC the separation was achieved using a Xbridge C18 (250x 4.6 i.d; 5µm) column with isocratic elution using a mobile phase consisting of methanol: acetonitrile (80:20v/v/ with 0.1% v/v TEA) adjusted to pH 5.2 with glacial acetic acid at 1mL/min flow for 10min. Benidipine and Telmisartan, were detected at dual wavelength at 237 and 297nm with retention time (Rt) 6.891 and 8.997 minutes respectively. Results: Our new methods (RP-HPLC) were found to (r2>0.999) for both Benidipine and Telmisartan. The developed methods are highly selective, precise and reproducible with %RSD < 2%, Moreover the methods are accurate with recovery more than 99% in both methods. Conclusion: The RP-HPLC method results are efficient, simple and easy. These highly sensitive methods were successfully applied for assay determination of both Benidipine and Telmisartan at fixed dose combination.