Objective: The objective of the study was to develop and validate a new rapid and sensitive reverse phase ultra-performance liquid chromatographic (RP-UPLC) method for determination of cefdinir in bulk drug and dosage form.Methods: Separation was achieved with an Acquity SB C18 (100 × 2 mm) 1.8μm column with an isocratic mobile phase containing a mixture of orthophosphoric acid and acetonitrile (60:40 v/v) and pH adjusted to 2.8. The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30 °C and detection wavelength at 285 nm. Results:The method was validated with respect to linearity, accuracy, precision, detection limits, robustness and specificity. The precision of the results, stated as the relative standard deviation was below 1.5%. The calibration curve was linear over a concentration range from 25 to 150μg/ml with a correlation coefficient of 0.9993. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The recovery of cefdinir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.17 and 0.51µg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stabilityindicating ability of the developed UPLC method. Conclusion:The developed method was validated with respect to linearity, accuracy, precision limit of detection and quantification, robustness and specificity. The method was applied successfully for the determination of cefdinir in tablets.
Objective: Azelnidipine (AZEL) and Telmisartan (TELM) combination is referred to the sufferers of hypertension. No analytical process has yet been mentioned for the TELM and AZEL combination analysis. We, therefore, have designed for its first time stability demonstrating methodology based on HPLC for analysing TELM and AZEL in the tablets and bulk. Methods: The assay of TELM and AZEL was get done on a 250 mm length C18 column (Supelco, 4.6 mm inner diameter, 5.0 μm particle size), and utilized 0.1M Na2SO4 (pH 3.6) and acetonitrile (55% volume: 45% volume) as the mobile solvents phase, at a stream rate 1.0 ml/min. HPLC recognition of TELM and AZEL was taken by a photodiode array sensor set at 258 nm. For validation of the stability demonstrating methodology proposed in terms of sensitivity, precision, specificity, linearity, device adequacy, robustness and accuracy, ICH directives were followed. Results: Calibration curves of TELM and AZEL were generated in the array of 20-60 µg/ml and 4-12 µg/ml with recovery percentage ranges of 99.62%-101.05% and 97.76%-100.17%, and detection limits of 0.020 µg/ml and 0.009 µg/ml, respectively. TELM and AZEL stability was inspected in the existence of acid, base, light, heat, and oxidation and it was realised to be more stable under oxidation degradation testing conditions employed when compared to acid, alkaline, photo, and heat degradation testing conditions applied. Conclusion: The observations demonstrated that the described HPLC stability demonstrating methodology was suitable for quantitating TELM and AZEL combination in tablets and bulk.
Sustained-release matrix tablets allow for continuous drug release while also optimizing a drug's biologic, pharmacokinetic, and pharmacodynamic properties for maximum therapeutic efficacy. The matrix regulates the rate at which the drug is released. Because it facilitates prolonged release, the major excipient in the formulation is a release retardant. The technology may promote patient compliance and efficiently treat chronic illnesses by decreasing the overall dosage and dosing schedule. The drug is supplied in this system via diffusion- and dissolution-controlled methods. The primary goal of this analysis is to provide comprehensive information on the sustained release system and to discuss the many selection criteria for medicines used in medication administration system
A new rapid, accurate, precise and economical reverse phase high performance liquid chromatographic method has been developed and validated for simultaneous estimation of Methylcobalamin, Epalrestat and Pregabalin in bulk and pharmaceutical dosage form. The separation was accomplished utilizing Agilent C18, 150 x 4.6mm, 5 column at a detection wavelength of 210nm utilizing the mobile phase water and acetonitrile 60: 40 v/v at the flow rate of 0.8ml/min and injection volume of 10µl. The total run time was 6.0 min. Validation discovered the method was specific, rapid, accurate, precise, reliable and reproducible. The calibration curve was linear over the concentration range of 0.37 – 2.25μg/ml of Methylcobalamin, 37.5-225μg/ml of Epalrestat and 37.5-225μg/ml of Pregabalin respectively with correlation coefficient of 0.999. The accuracy was determined by recovery studies and was found to be 99.5-100%. The precision of the results stated that the %RSD was <2%. The limits of detection for Methylcobalamin, Epalrestat and Pregabalin were 0.2, 0.9 and 1.2μg/ml, while the limits of quantification were 0.5, 1.5 and 0.9μg/ml respectively. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed HPLC method. The high recovery confirms the suitability of developed method and can be further used in routine analysis.
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