Objective: The aim of the present study is to screen for the phytochemical constituents which are of pharmacological importance present in the ethanolic extract of whole plant of Sida glutinosa (SG). Methods: The ethanolic extract of the dried whole plant of SG is subjected to preliminary phytochemical screening which showed the presence of major phytoconstituents such as phenols, flavonoids, and alkaloids. The extract was screened for its antioxidant activity by 2,2-diphenyl-1- picrylhydrazyl, hydroxyl radical, Iron (III) to Iron (II) reducing activity, and nitric oxide scavenging assay. Further, the ethanolic extract was subjected to fingerprinting technique high-pressure thin-layer chromatography (HPTLC). Reverse phase high-pressure liquid chromatography (Rp-HPLC) was performed to estimate the amount of total phenolics, flavonoids, and alkaloids quantitatively in isocratic mode. Results: Phytochemical screening of the ethanolic extract of the plant showed the presence of pharmacologically important constituents such as alkaloids, flavonoids, phenolics, and terpenoids. The study also revealed the potential antioxidant activity of the extract with IC50 value. The extract fingerprinting through HPTLC revealed the presence of various phytoconstituents. Rp-HPLC showed 0.35±0.12 μg/ml of total phenolics, 0.0013±0.05μg/ml of alkaloids, and 0.00081±0.08 μg/ml of flavonoids. Conclusion: Scientific evaluation of SG which has therapeutic significance was carried out which is an important concept for the standardization of the plant-based drug. Further, there is a need for isolation and characterization of the lead molecules their systemic evaluation for its pharmacological activities.
Objective: This study was aimed to develop a novel, selective, and sensitive reverse phase high performance liquid chromatography method for the detection and quantification of aripiprazole in pure form as well as in its pharmaceutical formulation.Methods: The chromatography was carried out on C18 Phenomenex Luna (250 × 4.6 mm × 5 μm) column using a mobile phase of 0.1% v/v orthophosphoric acid (pH 3.0), acetonitrile and methanol in the ratio of 40:50:10 (% v/v). The isocratic elution program was adjusted to 1.0 ml/minutes flow rate with 20 μl injection volume. The eluted components were monitored at 254 nm. The ambient column oven temperature was maintained.Results: The developed method was validated statistically with respect to linearity, range, precision, accuracy, specificity, robustness, ruggedness, detection and quantification limits and also subjected to various stress conditions such as acidic and alkaline hydrolysis, oxidation, photolysis, and thermal degradation. The method showed linearity across the concentration range of 10.0-60 μg/ml.Conclusion: The developed method is specific, precise, accurate, robust and stability indicating which can be successfully applied for routine analysis, quality control analysis and also suitable for stability analysis of assay of aripiprazole in pure form and its formulation as per the regulatory requirements.Keywords: Aripiprazole, Reverse phase high performance liquid chromatography, Stress condition.
A simple, authentic and stability indicating high performance liquid chromatographic method for determination of Canagliflozin in bulk and pharmaceutical formulations was developed and validated as per ICH Q2 R1 Guidelines, A C18 Column (250mm length×4.6 mm diameter x 5 μm particle size) with a mobile phase consisting of Acetonitrile: 1-octanesulphonic acid in a ratio of 70:30 v/v was employed for the chromatographic study. A flow rate of 1.0 mL/min with an injection volume of 20 μL was selected for this study and the proposed method was validated with different parameters such as Linearity, Precision, Accuracy, Robustness, Ruggedness, Limit of Detection (LOD) and Limit of Quantification (LOQ). Canagliflozin was eluted at 3.4 ± 0.5 min and detected at 245 nm. The method is linear over the concentration range of 10-100 μg/mL with correlation co-efficient r = 0.9997. The plate count and tailing factor was found 5398 and 1.05 respectively. The LOD and LOQ were found to be 0.0170 μg/mL and 0.1705 μg/mL respectively. The percentage recovery was achieved in the range of 98-102%, which was within the acceptance criteria. Developed method was employed to determine the amount of Canagliflozinpresent in dosage form (Sulisent). The stabilityof the method was demonstrated by forced degradation studies of drug in which it was degraded under conditions of hydrolysis (acidic and alkaline), oxidation, photolytic and thermal stress as per ICH guideline Q1A (R2).
Objectives: Maintaining the quality of the pharmaceutical drug product during its shelf life is highly desirable. The crystalline form of the drug having the great thermodynamic stability is essential for the manufacturers in pharmaceutical industry in view of their profit and also for the safety of the customer. Many pharmaceutical drugs have the tendency to exhibit polymorphism which is unwanted for pharmaceutical companies, where they have experienced market shortages due to these unpredicted polymorphic and/or pseudomorphic changes. The property of a drug exhibiting more than one crystal form is considerably regarded as polymorphism and each of the crystalline form has its own physicochemical properties, namely, solubility, heat capacity, melting point, and sublimation point. To relieve this ultimate effect on the drug quality and stability, a prior detection of polymorphism in the final dosage form is highly recommended. Hence, many analytical techniques have been proposed for the detection of polymorphism in pharmaceutical drug products. Methods: Fourier transform (FT)-Raman spectrometer is used for the investigation of drug polymorphism and the instrument is advanced with charge coupled device detectors, ease of sample preparation and handling, mitigation of sub-sampling problems using different geometric laser irradiance patterns and having different optical components of Raman spectrometers. Results: In this work, we carefully studied the Raman spectral patterns for Lamivudine as well as Finasteride drug substances for the detection of polymorphism. Further, we have highlighted the advantages of FT-Raman spectroscopy over other polymorphism detection techniques. For example, Raman spectra showed invariably sharp, well resolved bands compare to IR spectra due to the minor contribution of overtone vibrations in Raman spectra, resulting in much less broadening and a better resolution of bands. Besides, Raman spectroscopy does not suffer from the sampling problems that are common in X-ray powder diffraction, where preferred orientation and specimen displacements are serious restrictions for the application of quantitative method. Conclusion: Here, in this paper, we are presented and compared the experimental results regarding the detection of polymorphism in Lamivudine and Finasteride drugs using FT-Raman spectroscopy, to illustrate the advantages of the technique in the detection of polymorphism over other techniques.
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