Method Development and Validation of Ciprofloxacin HCL and Ornidazole by UFLC in Combined Dosage Form

Shivabasappa, Palled Mahesh; Diksha, Hadaki; Chouhan, Mahendra Kumar; Jalalpure, Sunil; Suryawanshi, Shailendra S.

doi:10.5530/ijper.53.3s.108

Cited by 2 publications

(1 citation statement)

References 5 publications

(6 reference statements)

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“…The developed UV-spectrophotometric method was validated as per ICH guidelines in terms of specificity, selectivity, linearity, LOD, LOQ, precision, ruggedness and accuracy. [55][56][57][58][59][60]…”

Section: Methods Standardizationmentioning

confidence: 99%

Marker Based Standardization of Quercetin in Marketed Capsules by Novel Zero Order Spectroscopic and Area Under Curve Spectroscopic Methods

Surve,

Tavanoji,

Nadaf

et al. 2023

Ind. J. Pharm. Edu. Res.

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Background: Quality control and standardization of phytomedicines play a vital role in herbal drug industries. Marker based quantification and standardization is one of the essential approaches used in quality evaluation of herbal products. The Quercetin is an important flavonoid having variety of therapeutic activities and many formulations are available in the market. Capsule dosage form of Quercetin is largely marketed. The main objective for analytical development of proposed research is to develop and validate marker-based quantification of analytical methods to carry out quality control of Quercetin along with its standardization in marketed Ayurvedic capsule formulation. Materials and Methods: In the proposed analytical research work two novel UV-spectrophotometric methods mainly Area Under Curve (AUC) spectroscopic and zero order spectroscopic methods were developed and also validated for marker-based quantification of Quercetin. The development of both UV-spectrophotometric methods was carried out by using water: methanol (50:50%v/v) as a solvent. In zero order spectroscopic method absorbance of Quercetin was measured at 372nm. The detection of Quercetin was carried out at 372nm. The area covered between 325nm to 402nm was used for calculation. Results: Quercetin exhibits λ max at 372nm obeying Beer's law at concentration ranges lying between 2-10μg/mL giving r 2 values of 0.9997 and 0.9992 respectively using absorbance and area under curve method. The validation parameters for all these methods were found to be well within the acceptance values. Both UV-spectrophotometric methods showed excellent recovery values between 98 to 107%. Both newly developed and validated marker-based quantification methods were successfully applied for estimation of Quercetin in its marketed capsule dosage form. Conclusion: The proposed research work concludes that these two developed UV-Spectrophotometric methods were new, simple, precise, and accurate for marker-based quantification of Quercetin in marketed formulation.

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Section: Methods Standardizationmentioning

confidence: 99%

Marker Based Standardization of Quercetin in Marketed Capsules by Novel Zero Order Spectroscopic and Area Under Curve Spectroscopic Methods

Surve,

Tavanoji,

Nadaf

et al. 2023

Ind. J. Pharm. Edu. Res.

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Validation of HPLC-DAD Based Stability Indicating Assay Method for Ornidazole in Periodontal Polymeric Hydrogel: Robustness Study using Quality by Design (QbD) Approach

Agrawal,

Hakami,

Khan

et al. 2024

LCGC Int.

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In the present study, a gradient reversed-phase high-performance liquid chromatography (RP-HPLC) method has been designed and validated to quantify Ornidazole (OZ) in the marketed formulation (oral gel) with the application of QbD. The proposed HPLC method utilizes an RP C18 column (4.6 x 250 mm, 5 μm). The mobile phase contained HPLC grade Solvent A (water) and Solvent B (acetonitrile) and ran at a flow rate of 1 mL/min in a gradient mode. The linearity was plotted in an OZ range of 1–12 μg/mL and the correlation coefficient was found to be 0.9998. The limit of quantification, as well as the limit of detection, has been recorded as 0.70 μg/mL and 0.23 μg/mL. Inter- and intra-day precision (RSD) percentages were reported respectively within a range of 0.262–0.589 and 0.179–0.879. At 80, 100, and 120 percent different OZ levels, the average accuracy was 99.55, 99.58, and 99.92, respectively. The result of the study indicates that the OZ gel estimate HPLC method has good sensitivity, reproducibility, accuracy, and precision. This method may be used for the estimation of OZ in a gel formulation in quality control laboratories.

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Method Development and Validation of Ciprofloxacin HCL and Ornidazole by UFLC in Combined Dosage Form

Cited by 2 publications

References 5 publications

Marker Based Standardization of Quercetin in Marketed Capsules by Novel Zero Order Spectroscopic and Area Under Curve Spectroscopic Methods

Marker Based Standardization of Quercetin in Marketed Capsules by Novel Zero Order Spectroscopic and Area Under Curve Spectroscopic Methods

Validation of HPLC-DAD Based Stability Indicating Assay Method for Ornidazole in Periodontal Polymeric Hydrogel: Robustness Study using Quality by Design (QbD) Approach

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