METHOD DEVELOPMENT AND VALIDATION OF NORETHINDRONE ACE-TATE ASSAY AND ITS RELATED IMPURITIES IN API AND PHARMACEUTICAL FORMULATION WITH ORTOGONAL DETECTOR TECHNQUES
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2017, Vol 9, Issue 12
Abstract
Objective: To develop and validate a sensitive and stability indicating gradient reverse phase ultra-high performance(UHPLC-PDA) liquid chromatography with photodiode array(PDA) and mass spectroscopy (MS) of Norethindrone Acetate (NA) assay and organic impurities (OI) in active pharmaceutical Ingredient(API) and Pharmaceutical Formulation (PF).Methods: The chromatographic conditions were optimized using Zorbax SB-C18 analytical UHPLC column with the dimensions (100 x 2.1) mm and 1.8 μm particle sizes. The mobile phase consisted of water (solution A) and acetonitrile (solution B) with gradient elution as mentioned time (min)/% Solution B: Initial/40,0.2/40, 9.2/55,12.0/55,12.2/90,15.5/90, 15.8/40 and 18.0/40. The flow rate was at the rate of 0.4 ml/min and the detection wavelengths were 254 nm and 210 nm. The column was kept at 40 °C and the injection volume was 5 μL. Stability of NA sample in different conditions was investigated by exposing the drug to stress study utilizing acid, base, oxidation, thermal, Humidity and photolytic.Results: There was no interference from excipients, impurities or degradation products at the retention time of NA about 9.1 min indicating the specificity of the method.The drug showed good stability under oxidation, thermal, humidity and photolytic conditions, but significant degradation was observed under acid and base conditions. The procedure was validated for specificity, linearity, accuracy, precision and robustness. The degradation products were well resolved from NA and its impurities. The obtained LOD (Limit of detection) values are 0.001% to 0.015% and LOQ (Limit of quantification) values are 0.003% to 0.05% of impurities.Conclusion: A sensitive, rapid, specific and stability indicating gradient Reverse Phase UHPLC-PDA-PDA with MS (Orthogonal detectors) method for the determination of NA for the assay and organic impurities was successfully developed. The developed method was validated to be specific, linear, accurate, precise and robust. The peak purity and LC-MS test results confirmed that the NA peak was homogenous in all stress samples and the mass balance was found to be more than 99%, thus proving the stability indicating power of the method
Authors and Affiliations
J. Satish, P. Radhakrishnanand, K. Surendra Babu
Keywords
Related Articles
- EP ID EP575409
- DOI 10.22159/ijpps.2017v9i12.19856
- Views 100
- Downloads 0
COMPARATIVE ANALYSIS OF ANTI-INFLAMMATORY ACTIVITY OF AQUEOUS AND METHANOLIC EXTRACTS OF C. CASSIA AND C. ZEYLANICUM IN RAW264.7, SW1353 AND PRIMARY CHONDROCYTES
Objectives: The objective of this research was to compare the anti-inflammatory activity of aqueous and methanolic extracts of C. cassia (CC) and C. zeylanicum (CZ) in mouse macrophage (RAW264.7) and human chondrosarcoma...
ESTIMATION OF ANTIOXIDANT AND ANTIBACTERIAL ACTIVITY OF CRUDE EXTRACTS OF THEVETIA PERUVIANA (PERS.) K. SCHUM.
Objective: The aim of this investigation was to estimate antioxidant and antibacterial activity of different crude extracts of Thevetia peruviana (Pers.) K. Schum.Methods: Aqueous and alcoholic crude extracts of differen...
ORAL BIOAVAILABILITY ENHANCEMEMENT OF BROMOCRYPTINE MESYLATE BY SELF-MICRO EMULSIFYING DRUG DELIVERY SYSTEM (SMEDDS)
Objective: The purpose of this work was to enhance oral bioavailability of Bromocryptine Mesylate by preparing SMEDDS (self-micro emulsifying drug delivery system)Methods: Screening of oils, surfactants and co-surfactant...
ANTI-INFLAMMATORY ACTIVITY OF HMG CO A REDUCTASE INHIBITORS: A COMPARATIVE STUDY
Objective: The purpose of the present study was to reveal the potential pleotropic anti-inflammatory activity of two hmg-co Reductase inhibitors, Rosuvastatin and atorvastatin in comparison with standard drug diclofenac....
THE APPLICATION OF COMMUNICATION TECHNOLOGY IN HOSPITAL AND COMMUNITY PHARMACIES: A BRIEF REVIEW
The use of communication technology has brought positive changes to the healthcare delivery system of today. Both healthcare professionals and patients have found a better option to access relevant health and drug inform...