The present study accurate and precise RP-HPLC method has been developed for the validated of Tenofovir Alafenamide and Emtricitabine, in its bulk and Combined Tablet dosage forms. Chromatography was carried out system C18 (4.6 x 150mm, 5µm) column using a mixture of Acetonitrile: ortho phosphoric acid bufferadjusted pH 2.5 (55:45v/v) as the mobile phase at a flow rate of 1.2 mL/min, the detection was carried out at 266 nm. The retention time of the Tenofovir alafenamide and Emtricitabine were found 2.1 and 3.4 minand respectively. The method produce linear responses in the concentration range of 5-30µg/mL of Tenofovir alafenamide and40-240µg/ml of Emtricitabine. The method precision for the determination of assay was below 2.0%RSD. The Proposed RP-HPLC method is useful in the quality control of bulk drug and Tablet dosage forms.
Gandla. Kumara Swamy*, M. Rajkumar, K. Pranay, D. Sudheer Kumar.
Analysis of plant screening for phytochemical constituents seems to have the potential to act as a source for useful drugs for many infections because of various bioactive compounds present that have activity against array of human pathogens. Pteleopsis habeensis is widely use in Northern part of Nigeria for management of a number of ailment. Whole plant of P. Habeensis was extracted using methanol by maceration and extracts was screened for presence of phytochemicals and free radical scavenging activity using standard procedures. The phytochemical result indicated P. Habeensis contains Alkaloids, Flavonoids, Tannins, Anthraquinones, Saponins, Steroids, Cardiac glycosides and Terpenoids. The DPPH Assay showed high free radical scavenging activity of the extract that is comparable to Ascorbic acid. Statistically, no significant difference between antioxidant property of the extract and standard. The presence of such phenolic compounds suggest the medicinal value of the plant and the bioactive constituents can be isolated for pharmaceutical use.
Falmata M. Aliyu*, Abdulqadir Bababe, Mohammed Kachallah, H. B. Yesufu, Fatima A. Goje, Emmanuel A. Gwa.
UV Spectrophotometric Method Development and Validation for quantitative estimation of Miconazole nitrate (MIC). U.V Spectrophotometric method have been widely employed in determination of individual components in a mixture or fixed dose combination. Our aim is to develop spectroscopic method for estimation of the Miconazole nitrate (MIC) in ternary mixture by using U.V spectrophotometry. The method was validated as per ICH guidelines. The recovery studies confirmed the accuracy and precision of the method. It was successfully applied for the analysis of the drug in bulk and could be effectively used for the routine analysis.
A accurate and precise RP-HPLC method has been developed for the validated of Sofosbuvir and Velpatasvir in bulk and combined Tablet dosage form. Separation was carried out on a Primesil C18 (4.6 x 250mm, 5µm) column using a mixture of Acetonitrile: 0.1% perchloric acid (50:50 v/v) as the mobile phase at a flow rate of 1.2mL/min, the detection was carried out at 262 nm. The retention time of the Sofosbuvir and Velpatasvir 4.25, 6.05 min respectively. The method produce linear responses in the concentration range of 25-150 µg/mL for Velpatasvir, and 100-600µg/ml of Sofosbuvir. The method precision for the determination of assay was below 2.0% RSD. The proposed method was successfully validated as per ICH validation parameters.
Gandla. Kumara Swamy*, K. Pranay, M. Rajkumar, R. Lalitha.
A simple and selective RP-HPLC method is described for the simultaneous determination of Rilpivirine, Emtricitabine, and Tenofovir alafenamide dosage forms. Chromatographic separation was achieved on a Inertsil C18 Column(150x4.6 mm, 5 µmparticle size)using mobile phase consisting of a mixture of mixed 0.1N Phosphate buffer( pH: 4): Acetonitrile (40:60v/v), with detection of 275nm. Linearity was observed in the range 3-10 µg/ml for Rilpivirine (r2 =0.996) 20-60 µg /ml for Emtricitabine (r2 =0.9967), 30-70µg /ml for Tenofovir alafenamide (r2 =0.995) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery studies indicated that the absence of additives interference. Repeatability analysis of the method was found to be precise, showing %RSD less than 2.
K. Kranthi Kiran*, A. Srinivasa Rao, Dannana Gowri Sankar.