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K. Bala Durga Devi ¹, P. Vijayalakshmi ¹, V. Shilpa ¹, VSSL Prasad T ¹, B. Veerendra Kumar ¹

Affiliations
1 Department of Biotechnology, GITAM Institute of Sciences, GITAM University, Visakhapatnam-530 045, Andhra Pradesh, IN

Abstract

The current study focused on the optimization of kojic acid production by a soil isolated fungal organism Aspergillus flavus through Surface Fermentation (SF) by utilizing a novel carbon source i.e. ripened fruits of Muntingia calabura L. Initially the most significant 7 physico-chemical factors were studied for the optimization process through One-Factor-At-A-Time Method (OFAT). Among these 5 influential factors were screened and five-factor-three-level Central Composite Design (CCD) matrix and Response Surface Methodology (RSM) was performed to enhance the production rate of kojic acid. Through one-factor-at-a-time method the optimal values were Substrate concentration 100g/L, Peptone concentration 4g/L, KH₂PO₄ concentration 2g/L, MgSO₄ concentration 0.7g/L, pH 6.0, Time 28d and Temperature 30°C and the maximum kojic acid production was 85.1g/L. The maximum production obtained at the predicted optimal conditions through response surface methodology was Substrate concentration 100g/L, Peptone concentration 4g/L, pH 6.0, Time 28d and Temperature 29°C and the maximum kojic acid production was 88.8 g/L. These results directs to the success of the model in improving a process for the production of kojic acid, a significant organic acid with vast industrial importance.

Keywords

Kojic Acid, Muntingia calabura L, One-Factor-at-a-Time Method, Optimization, Response Surface Methodology.

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A. Kirthi ¹, R. Shanmugam ¹, S. Mohana Lakshmi ², C. K. Ashok Kumar ², K. Padmini ³, M. Shanti Prathyusha ¹, V. Shilpa ¹

Affiliations
1 Department of Pharmaceutical Analysis, Sree Vidyanikethan College of Pharmacy, Tirupati-517102, Andhra Pradesh, IN
2 Department of Pharmacognosy, Sree Vidyanikethan College of Pharmacy, Tirupati-517102, Andhra Pradesh, IN
3 Department of Pharmaceutical Chemistry, Sree Vidyanikethan College of Pharmacy, Tirupati-517102, Andhra Pradesh, IN

Abstract

Danazol is an endocrine metabolic agent or anti gonadotropin drug. The aim of this study was to develop a accurate, specific, linear, simple, rapid, precise, reliable and stability indicating RP-HPLC analytical method for the determination of Danazol in pharmaceutical dosage form. The chromatographic separation was performed using phenomenex C₁₈ column (150X4.6mm, 5μm) in RP-HPLC with mobile phase consisting of acetonitrile:potassium dihydrogen orthophosphate (70:30, v/v) with flow rate of 1ml/min and detection wave length at 285nm was optimized and fixed. The Danazol was properly resolved with a run time of 4.9 min. Linearity was performed for Danazol in the range of 10-120μg /ml (R²=0.9986). The percentage recovery for Danazol was found to be 98.87%-100.69%. The developed analytical method has been validated in terms of accuracy precision, specificity, linearity, and robustness which were within the acceptance limit according to ICH Q2 (R1) guidelines. Danazol was subjected to stress conditions including acidic, alkaline, oxidation, and thermal degradation and drug found to be more sensitive towards alkaline hydrolysis and all the degradation products were found to be well separated from the principal peak, which means that the Danazol peaks were highly pure in all chromatograms obtained. The results represents that the developed method was successfully employed for the routine quality control and stability analysis of Danazol in pharmaceutical dosage forms.

Keywords

RP-HPLC, Validation, Danazol, Stability Indicating, ICH Guidelines.

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