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Accelerated Stability Studies on Valacyclovir ...

INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 2277 5005. Research Article Accelerated Stability Studies on Valacyclovir Hydrochloride by RP-HPLC. VMK. Gowtham Potnuru, C. Jothimanivannan*, CH. Arjun, M. Jambulingam, S. Ananda Thangadurai and D. Kamalakannan Swamy Vivekanandha College of Pharmacy, Department of Pharmaceutical Analysis. Elayampalaym, Tiruchengode, Namakkal, Tamilnadu, India. ABSTRACT. A specific, accurate, precise and sensitive RP-HPLC method has been developed for the determination of Valacyclovir hydrochloride in the presence of its degradation products by Accelerated Stability Studies .

INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 2277 5005 Vol. 2 (1) Jan-Mar 2013 www.ijpcsonline.com 110

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Transcription of Accelerated Stability Studies on Valacyclovir ...

1 INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 2277 5005. Research Article Accelerated Stability Studies on Valacyclovir Hydrochloride by RP-HPLC. VMK. Gowtham Potnuru, C. Jothimanivannan*, CH. Arjun, M. Jambulingam, S. Ananda Thangadurai and D. Kamalakannan Swamy Vivekanandha College of Pharmacy, Department of Pharmaceutical Analysis. Elayampalaym, Tiruchengode, Namakkal, Tamilnadu, India. ABSTRACT. A specific, accurate, precise and sensitive RP-HPLC method has been developed for the determination of Valacyclovir hydrochloride in the presence of its degradation products by Accelerated Stability Studies .

2 As per ICH guideline Q1A (R2), drug was subjected to all stress conditions such as hydrolysis (acidic and alkaline), oxidation (30% H2O2 v/v), photolysis, (As per ICH guideline Q1B), thermal degradation and humidity study. All stressed samples were successfully analyzed on C18 column using mobile phase water: methanol: perchloric acid in the ratio of 95:4:1v/v with a flow rate of ml/min and detection was made at 255 nm. Moderate change in Stability of drug was shown in thermal and oxidative Studies whereas drug was found to be stable in acid, alkali, humidity and photolysis Studies .

3 The developed method was validated over the linearity, precision, accuracy and specificity as per ICH. guideline Q2B. The major degradants was identified as acyclovir and D- Valacyclovir hydrochloride through comparison with the standard. The developed method with good separation of all degradation products from drug could be successfully applied for the determination of Valacyclovir hydrochloride in the presence of its degradation products in formulation. It can be used for analysis of samples during Stability testing.

4 Keywords: Valacyclovir hydrochloride, RP-HPLC, Forced Degradation. INTRODUCTION integral part of the systematic approach to Valacyclovir is, L-Valine 2-[(2 amino 1, Stability evaluation. Stress testing of the 6 dihydro 6 oxo 9H-purin 9yl) methoxy] drug substance can help identify the likely ethyl ester (Fig 1). After oral degradation products, which can in turn administration Valacyclovir is rapidly help establish the degradation pathways converted into acyclovir which has and the intrinsic Stability of the molecule demonstrated antiviral activity, against and validate the Stability indicating power herpes simplex virus type I (HSV-1) and 2 of the analytical procedures used.

5 The (HSV-II), Varicella zoster virus (VZV). nature of the stress testing will depend on Valacyclovir is available as tablet dosage the individual drug substance and the type form in the market. Few HPLC methods of drug product involved. Stress testing is were reported for the determination of likely to be carried out on a single Valacyclovir in its pharmaceutical substance10. The main objective was to formulation and in serum. Previously develop a suitable method of analysis reported HPLC methods using C18, C8 with which is Stability indicating and to get an flow rate 3, 1 ml/min respectively our idea of how drug substance or product reported liquid chromatographic method degrades, degenerates and behaves determined Valacyclovir in presence of under changing conditions by keeping all acyclovir using C18 with flow rate this in view, it was thorough worthwhile to ml/min1-8.

6 The ICH guideline Q1A (R2)9 develop Stability indicating HPLC method emphasizes that the testing of those for Valacyclovir pure drug and its tablet features which are susceptible to change dosage form. Literature survey revealed during storage and are likely to influence that few methods are reported for the quality, safety and efficacy, must be done determination of Valacyclovir in the by validated Stability indicating testing presence of its degradation product in method. As per Q1A (R2) information on pharmaceutical dosage form.

7 The Stability of the drug substance is an Vol. 2 (1) Jan-Mar 2013 110. INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 2277 5005. EXPERIMENTAL solution in to a 10 ml dry, clean volumetric Chemicals and Reagents: flask and the volume was made up to Valacyclovir hydrochloride (standard) is mark with mobile phase (120 g/ml). The obtained from Aurobindo Pharma Ltd., solution was filtered and sonicated to Hyderabad, , India. Methanol, remove water bubbles. Twenty micro liters Perchloric acid, Water, Hydrogen of solution was injected into system, the peroxide, Hydrochloric acid, Sodium chromatogram obtained was shown in hydroxide etc.

8 , which are of analytical Figure 2. grade reagent were purchased from E. Merck Ltd., Mumbai, India. Double distilled Sample preparation water was used throughout the study. Ten tablets were accurately weighed and Pharmaceutical dosage form (tablet) was powdered. The equivalent weight of 60 mg obtained from local market, manufactured of tablet powder was transferred into a by Cipla Pharma Ltd., as a brand name of 100 ml dry, clean volumetric flask and the Valcivir 500 mg which was used as volume made up to the mark with diluent sample.

9 (600 g/ml). From this 2 ml was pipetted out in to a 10 ml dry, clean volumetric Instrumentation flask and the volume was made up to Analysis was performed on a mark with mobile phase (120 g/ml). The chromatographic system of Waters 2629 solution was filtered and sonicated to equipped with an auto injector with remove water bubbles. UV/Visible detector (UV-2489). A. chromatographic separation was achieved Forced degradation Studies (stress on Crownpak C18 column (5 m, 250mm x testing). , ) analytical column. Data Acid degradation acquisition was made with Empower-2 The reaction was initiated by adding 10 ml software.

10 Analytical Balance (BSA224S- of Valacyclovir hydrochloride to 100 ml CW, Sartorius), pH Meter (Eutech) from volumetric flask containing 5 M. Shimadzu were used for the study. hydrochloric acid. The volume made to Thermal oven and humidity desiccator 100 ml with 5 M hydrochloric acid. The were used to find Stability of drug. degradation was carried out in thermostatically controlled water bath, Chromatographic conditions protected from light. The degradation was Valacyclovir hydrochloride chromatogram carried at 850c temperature for 60.


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