DEVELOPMENT OF A STABILITY-INDICATING UPLC METHOD FOR DETERMINING ZIPRASIDONE HYDROCHLORIDE AND ITS ASSOCIATED DEGRADATION PRODUCTS PRESENT IN ACTIVE PHARMACEUTICAL INGREDIENTS AND PHARMACEUTICAL DOSAGE FORMS

2013 ◽  
Vol 36 (7) ◽  
pp. 968-982 ◽  
Author(s):  
Shiva Raj ◽  
K. Siva Kumari ◽  
Ch. Krishnaiah ◽  
A. Narasimha Rao
Keyword(s):  
Degradation Products ◽  
Dosage Forms ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Pharmaceutical Ingredients

DEVELOPMENT AND VALIDATION OF AN IMPROVED STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF TROXIPIDE IN BULK AND TABLET DOSAGE FORMS

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (07) ◽  
pp. 18-22
Author(s):  
D. Gowrisankar ◽  
◽  
N.M Rao
Keyword(s):  
Degradation Products ◽  
Thermal Conditions ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Improved Stability ◽  
Degradation Studies ◽  
Tablet Dosage

An improved stability-indicating RP-HPLC method was developed for the estimation of troxipide in bulk and tablet dosage forms. Chromatographic separation of troxipide from its degradation products was achieved on Agilent Zorbax SB-CN (150 × 4.6 mm, 3.5 μm) using sodium phosphate buffer (pH was adjusted to 4.0 ±0.05) and acetonitrile in the ratio of 40:60 V/V, at a flow rate of 0.8 mL/min. This system was found to give compact peak for troxipide at 2.1±0.2 min. The detection was monitored at 260 nm. The linear regression data for the calibration plots showed good relationship with r2 = 0.99 ± 0.001. The method was validated for precision, linearity, accuracy and robustness according to International Conference on Harmonization (ICH) guidelines. The percentage RSD was found to be less than two, indicating high degree of accuracy and precision of the proposed RP-HPLC method. The drug was subjected to stress degradation studies under acidic, basic, oxidative and thermal conditions. The degradation studies reveal that purity angle was less than the purity threshold, so the peak was said to be pure. It means that products resulting from stress studies did not interfere with the detection of troxipide and the assay can thus be considered as stability-indicating. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method may be used for determining troxipide in bulk and in pharmaceutical dosage forms.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ETHINYL ESTRADIOL AND GESTODENE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

2021 ◽  
pp. 49-58
Author(s):  
D. SUCHITRA ◽  
BATTU SATYANARAYANA
Keyword(s):  
Ethinyl Estradiol ◽  
Degradation Products ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Active Pharmaceutical Ingredients ◽  
Economic Stability ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Pharmaceutical Ingredients ◽  
Rp Hplc

Objective: The principal objective of this study is to develop and validate a simple, new, fast, selective, precise, and economic stability-indicating the RP-HPLC method for the simultaneous estimation of Ethinyl estradiol and Gestodene in a bulk and pharmaceutical dosage form. Methods: The present method was developed and validated on a Waters HPLC system using Phenomenex Gemini C18(250 mm × 4.6 mm i.d., 5 µm particle size) column and mobile phase composition of phosphate buffer: Acetonitrile (75:25 v/v) and the pH was adjusted to 3.6 using dilute orthophosphoric acid. The system was regulated at 1.0 ml/min flow rate at 237 nm UV detection. Results: The two drugs Ethinyl Estradiol and Gestodene, were eluted at 1.788 min and 3.475 min retention time, respectively. The analytical parameters such as accuracy, precision, linearity, LOD, LOQ, ruggedness, and robustness were used for validating the developed method according to International Conference on Harmonisation [ICH] guidelines. Linearity was exhibited over the concentration range of 10-50µg/ml and 25-125µg/ml for Ethinyl Estradiol and Gestodene, respectively. The method revealed the Limit of Detection and Quantitation values for Ethinyl Estradiol and Gestodene were 1.399µg/ml, 3.909µg/ml and 4.24µg/ml, 11.85µg/ml, respectively. The stress testing was carried out to give rise to degradation products by exposing the drugs to acid, alkali, thermal, oxidative, photolytic, and hydrolytic degradation. The obtained data showed that the content of Active pharmaceutical ingredients and the degradation products were successfully separated without any interference, which confirmed the stability-indicating nature of the developed method. Conclusion: The new, simple, rapid, selective, precise, and economic stability-indicating RP-HPLC method has been successfully developed and validated. It can be satisfactorily applied for the periodic laboratory quantitative estimation of Ethinyl Estradiol and Gestodene in formulations and active pharmaceutical ingredients.

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