RP-HPLC method for simultaneous estimation of lamivudine, tenofovir disoproxil fumarate and efavirenz in tablet formulation

Objective: The present work was focused on the development and validation of reversed-phase high-performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of rosuvastatin (RSV) calcium and clopidogrel bisulfate (CLO) in bulk and tablet formulation. Methods: The separation was attained on RP Princeton (C18) column with dimensions (250 mm × 4.6 mm, 5 μ) employing buffer which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid), and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min and detection was carried out at wavelength 240 nm. The retention time under the optimized condition of RSV calcium and CLO was found to be 2.844 min and 4.388 min, respectively. Results: The linearity of the method was demonstrated in the concentration range of 6–16 µg/ml and 45–120 µg/ml for RSV calcium and CLO with a correlation coefficient (r2) of 0.9999 and 0.9996, respectively. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12–101.37% and 99.72–101.09% for RSV calcium and CLO, respectively. Assay of marketed tablet formulation was found to be 98.99% and 99.92%, respectively. Conclusion: The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and could be used for regular quality control of RSV calcium and CLO in bulk and tablet formulations.

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DEVELOPMENT, EVALUATION AND RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF QUERCETIN, ELLAGIC ACID AND KAEMPFEROL IN A POLYHERBAL FORMULATION

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2021v13i3.41028 ◽

2021 ◽

pp. 183-192

Author(s):

SHALINI K. ◽

ILANGO K.

Keyword(s):

Quality Control ◽

Ellagic Acid ◽

Hplc Method ◽

Tablet Formulation ◽

Simultaneous Estimation ◽

Asparagus Racemosus ◽

Control Analysis ◽

Hydroalcoholic Extract ◽

Polyherbal Formulation ◽

Rp Hplc

Objective: The current study was planned to develop polyherbal tablet formulation, standardization and evaluation for mitigating the symptoms of polycystic ovarian syndrome (PCOS). To control the issue of PCOS in women by the utilization of newly developed polyherbal tablet formulation. Methods: The polyherbal tablets were prepared using a hydroalcoholic extract of the selected medicinal plants viz. Asparagus racemosus, Bauhinia variegata, Caesalpinia bonducella, Saraca asoca, and Symplocos racemosa with the help of a super disintegrant addition technique using crospovidone, kyron T-314 and pregelatinized starch in various percentages. Evaluation assessments such as pre-formulation studies, weight variation, hardness, friability, thickness, disintegration, IR compatibility and simultaneous estimation of quercetin, ellagic acid and kaempferol by RP-HPLC method were done. Results: The results reveal that preformulation and evaluation parameters were satisfactory and found to be within an acceptable limit. The Fourier transform infrared spectroscopy (FTIR) compatibility displays no chemical interaction amongst the hydroalcoholic extract of polyherbal formulation and excipients. In simultaneous estimation, the retention time of quercetin, ellagic acid, and kaempferol were found to be 4.86, 6.96 and 10.01 min respectively. The linearity of quercetin, ellagic acid and kaempferol were found in the range of 0-200 µg/ml with correlation coefficients (R2>0.997) within the tested ranges. The LOD and LOQ values of quercetin, ellagic acid and kaempferol were found to be 11.86, 2.63, 5.28 µg/ml and 35.95, 7.98, 16.00 µg/ml respectively. The % RSD values were found to be less than 2 showed the optimized method is precise. Conclusion: To conclude, the prepared polyherbal tablet and its quality control analysis revealed satisfactory pharmaceutical properties that fulfill within the limits of pharmacopeial standards. The RP-HPLC method for simultaneous estimation of quercetin, ellagic acid and kaempferol were simple, precise, accurate and consistent for the quantitative analysis and quality control examination of herbal formulations.

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