There are rising geologic and anthropogenic processes and as a result, now a days soils polluted by heavy metals have become more common and it is a problem across the globe. Soil polluted due to heavy metal can be freed from pollutants effectively by use of bioremediation process. It's a very well-known process and is used in situ, making it ideal to make soil free from pollutants as a part of crop establishment as well as restoration of soil which are being treated. Microorganisms as well as plants uses a variety of processes/methods to bioremediate the pollutants present in the different types of soils. Keywords: Heavy metal contamination, Remediation process, Soil pollutants, bioremediation process, soil pollutants
A new method of analysis with reverse phase chemistry was designed and developed. Validation for method of analysis was performed for its intended use to calculate assay and content uniformity of drug substance sitagliptin, metformin and empagliflozin in the drug products. The method has a run time of 10 minutes on X-bridge C18 column having 250 mm length, 4.6 mm internal diameter and Particle Size of 5µm, by the use of 0.1% Trifluoroacetic acid Buffer 40%: Methanol 40%: Acetonitrile 20% ratio as constituent composition in the proposed mobile phase and chromatography run at wavelength of 224 nm. The retention time of Metformin, Empagliflozin and Sitagliptin, were 3.383, 5.571 and 6.429 minutes, respectively. International Conference on Harmonization guideline was referred for validation. The method showed adequate sensitivity for precision, linearity and accuracy parameter (between the range 25-75μg/mL, 250-750μg/mL and 2.5-7.5μg/mL for sitagliptin, metformin and empagliflozin respectively). The percentage recoveries obtained for sitagliptin, metformin and empagliflozin are in the range of 98.0 – 102.0 %. As results are within the acceptance [1], hence the new developed and proposed method is suitable for quantification of one, two or three component drugs, separately or in combination.
A new, economical, simple, accurate, and precise RP-HPLC method was developed for simultaneous assay and content uniformity determination of Sacubitril and Valsartan in bulk and pharmaceutical dosage form. The separation of Sacubitril and Valsartan was achieved within 6 minutes on Phenomenex Luna C18 250 mm x 4.6mm and 5µm Particle Size, column using Acetonitrile: Methanol: Water (30:55:15% v/v/v) as the mobile phase. Detection was carried out at 250 nm wavelength. The retention time of Sacubitril and Valsartan was found to be 2.361 and 3.304 min, respectively. The validation of the developed method was performed in terms of specificity, accuracy, precision, linearity, the limit of detection, the limit of quantification as mentioned in International Conference on Harmonization (ICH) guidelines. The method showed adequate sensitivity concerning linearity, accuracy, and precision over the range 12-36 μg/ml and 13-39 μg/ml for Sacubitril and Valsartan, respectively. The percentage recoveries obtained for Sacubitril and Valsartan were found to be in the range of 98.00 – 102.00 %. The proposed method is suitable for use in quality-control laboratories for quantitative analysis.
Experimental data for preformulation study is significant to develop a stable and safe drug product and forms the basis of preliminary information required to develop and design the final formulation. The experience, knowledge of drug substance components and ingredients planned to use in formulation, plays an important role in designing the preformulation studies. Co-ordination between the departments such as mainly analytical research and formulation research in conducting these studiesi.e., interdepartmental co-ordination, exchange of information and knowledge to perform research experimentation is necessary, to understand the knowledge of the complete lifecycle of the drug product. Analytical chemistry deals with methods of analysis developed and planned to use for content determination of related substances/impurities leads to get noteworthyinformation required to develop stable formulation and to determine the stability of the drug product. The usage of multiple instrumental techniques for identification, estimation and characterization techniques are essential to get the results of the research studies. The cGMP and GLP requirements should be fulfilled and followed as per the respective country specific regulatory guidelines.
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