scholarly journals NOVEL NOVEL STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC ASSAY METHOD FOR SIMULTANEOUS ESTIMATION OF HYDROCORTISONE AND TETRACYCLINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

2019 ◽  
pp. 255-258
Author(s):  
MUNI SAI VARAGANTI ◽  
PRASANTHI CHENGALVA ◽  
ARUNA GUNDALA
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

Objective: A combination of hydrocortisone and tetracycline as topical ophthalmic ointment is used for skin irritations, eye infections, inflammation, skin infections, acne, and rashes. The objective of the current work is to a simple, rapid, accurate, and precise, stability-indicating reverse-phase liquid chromatographic method was developed for the simultaneous estimation of hydrocortisone and tetracycline in bulk and pharmaceutical dosage form. Methods: The separation was carried out in Discovery C18 column (250 × 4.6 mm, 5 μm) using mobile phase ratio of water (pH 2.2 adjusted with orthophosphoric acid):acetonitrile (40:60 v/v) in an isocratic elution mode with a flow rate of 1.0 ml/min at detection wavelength of 244 nm. The injection volume was 10 μl and the column temperature was set at 30°C. Results: The retention time for hydrocortisone and tetracycline was found to be 2.214 ± 0.001 min and 3.497 ± 0.001 min, respectively. Calibration curves were linear (r2=0.999) at a concentration range of 2.5–15 mg/ml for both hydrocortisone and tetracycline. The percentage recoveries were found to be 99.13–99.67% for hydrocortisone and 99.39–99.61% for tetracycline. Relative standard deviation was found to be 0.3% for both the drugs. Limit of detection and limit of quantification values of hydrocortisone and tetracycline were found to be 0.09 μg/ml and 0.27 μg/ml and 0.17 μg/ml and 0.52 μg/ml, respectively. The drugs were subjected to various stress conditions and found no interference of degraded products peak at the retention times of analyte peaks. Conclusion: A rapid and accurate reverse-phase high-performance liquid chromatographic method was developed for simultaneous estimation of hydrocortisone and tetracycline, and the method was validated as per the International Council for Harmonization guidelines. Hence, the developed method can be successfully applied for the simultaneous estimation of hydrocortisone and tetracycline in bulk and ointment formulation.

scholarly journals STABILITY-INDICATING REVERSE-PHASE HIGH- PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND DACLATASVIR IN PURE AND PHARMACEUTICAL FORMULATION

2019 ◽  
pp. 56-63
Author(s):  
SWETHA A ◽  
RAMYA KUBER B
Keyword(s):  
High Performance ◽  
Chromatographic Method ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Pharmaceutical Formulation ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

Objective: The objective of the study was to develop a novel, simple, sensitive, accurate, precise, and stability-indicating reverse-phase (RP) liquid chromatographic method for simultaneous estimation of sofosbuvir and daclatasvir in pure and pharmaceutical formulation. Methods: In the present work, chromatographic separation was done using stationary-phase discovery column (250 mm×4.6 mm; 5 μm particle size) and mobile phase consisting of 0.1N potassium dihydrogen orthophosphate buffer:acetonitrile (55:45, v/v), with the flow rate of 1 ml/min, and the detection of column effluents was achieved with photodiode array at 260 nm. Results: The retention time of sofosbuvir and daclatasvir was found to be 2.32 min and 3.06 min, respectively. Stability-indicating studies were conducted according to the guidelines of International Conference on Harmonization (ICH) Q1A R2, and validation of the method was done as per the ICH guidelines Q2R1. The linearity of the method was in the concentration range of 100–600 μg/ml and 15–90 μg/ml for sofosbuvir and daclatasvir, respectively. The correlation coefficients were found to be 0.9996 and 0.9996 for sofosbuvir and daclatasvir, respectively. The limit of detection and limit of quantification were found to be 0.19 μg/ml and 0.59 μg/ml for sofosbuvir and 0.02 μg/ml and 0.05 μg/ml for daclatasvir, respectively. Conclusion: The stability-indicating RP high-performance liquid chromatographic (RP-HPLC) method was novel, simple, precise, accurate, and sensitive for simultaneous estimation of sofosbuvir and daclatasvir in pure and pharmaceutical formulations. Hence, the developed method was adopted for qualitative and quantitative analysis of sofosbuvir and daclatasvir in pure and pharmaceutical formulations.

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